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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04713891




Registration number
NCT04713891
Ethics application status
Date submitted
25/11/2020
Date registered
19/01/2021

Titles & IDs
Public title
A Study of KF-0210 in Advanced Solid Tumors Patients
Scientific title
A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of KF-0210 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
KFCS001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Colorectal Cancer 0 0
Lung Cancer 0 0
Squamous Cell Carcinoma of the Esophagus 0 0
Gastric Cancer 0 0
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KF-0210 tablets, 120 mg
Treatment: Drugs - KF-0210 tablets, 240 mg
Treatment: Drugs - KF-0210 tablets, 450 mg
Treatment: Drugs - KF-0210 tablets, 600 mg
Treatment: Drugs - KF-0210 (dosage RP2D-2) + Atezolizumab
Treatment: Drugs - KF-0210 (dosage RP2D-1) + Atezolizumab
Treatment: Drugs - KF-0210 (dosage RP2D) + Atezolizumab

Experimental: Phase 1a: Cohort 1 - KF-0210 tablet will be administered at 120 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal.

Experimental: Phase 1a: Cohort 2 - KF-0210 tablet will be administered at 240 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal.

Experimental: Phase 1a: Cohort 3 - KF-0210 tablet will be administered at 450 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal.

Experimental: Phase 1a: Cohort 4 - KF-0210 tablet will be administered at 600 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal.

Experimental: Phase Ib, Cohort 1 - KF-0210 (dose RP2D-2, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years.

Experimental: Phase Ib, Cohort 2 - KF-0210 (dose RP2D-1, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years.

Experimental: Phase Ib, Cohort 3 - KF-0210 (dose RP2D, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years.


Treatment: Drugs: KF-0210 tablets, 120 mg
KF-0210 tablet will be orally administered as a single agent at 120 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.

Treatment: Drugs: KF-0210 tablets, 240 mg
KF-0210 tablet will be orally administered as a single agent at 240 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.

Treatment: Drugs: KF-0210 tablets, 450 mg
KF-0210 tablet will be orally administered as a single agent at 450 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.

Treatment: Drugs: KF-0210 tablets, 600 mg
KF-0210 tablet will be orally administered as a single agent at 600 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.

Treatment: Drugs: KF-0210 (dosage RP2D-2) + Atezolizumab
KF-0210 tablet will be orally administered at dosage RP2D-2 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.

Treatment: Drugs: KF-0210 (dosage RP2D-1) + Atezolizumab
KF-0210 tablet will be orally administered at dosage RP2D-1 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.

Treatment: Drugs: KF-0210 (dosage RP2D) + Atezolizumab
KF-0210 tablet will be orally administered at dosage RP2D once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability]
Timepoint [1] 0 0
From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))
Primary outcome [2] 0 0
Dose limiting toxicity (DLT) of KF-0210 [Tolerability]
Timepoint [2] 0 0
From Cycle 1 Day 1 to Cycle 1 Day 21, each cycle is 21 days.
Primary outcome [3] 0 0
Maximum tolerated dose (MTD) of KF-0210 alone [Tolerability]
Timepoint [3] 0 0
Up to 21 days after first administration in cycle 1, each cycle is 21 days
Primary outcome [4] 0 0
Change of Body Weight from Baseline [Safety]
Timepoint [4] 0 0
On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [5] 0 0
Change of Body Temperature from Baseline [Safety]
Timepoint [5] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [6] 0 0
Change of Pulse rate from Baseline [Safety]
Timepoint [6] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [7] 0 0
Change of Systolic pressure from Baseline [Safety]
Timepoint [7] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [8] 0 0
Change of Diastolic pressure from Baseline [Safety]
Timepoint [8] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [9] 0 0
Change of Heart rate from Baseline [Safety]
Timepoint [9] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [10] 0 0
Change of R-R interval from Baseline [Safety]
Timepoint [10] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [11] 0 0
Change of P-R interval from Baseline [Safety]
Timepoint [11] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [12] 0 0
Change of QRS complex from Baseline [Safety]
Timepoint [12] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [13] 0 0
Chang of QT interval from Baseline [Safety]
Timepoint [13] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [14] 0 0
Change of corrected QT (QTc) interval from Baseline [Safety]
Timepoint [14] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [15] 0 0
Change of Fridericia's Correction QT (QTcF) interval from Baseline [Safety]
Timepoint [15] 0 0
From screening to the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [16] 0 0
Change of Eastern Cooperative Oncology Group-Performance Status (ECOG PS) from Baseline [Safety]
Timepoint [16] 0 0
On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [17] 0 0
Change of Total Protein (TP) from Baseline [Safety]
Timepoint [17] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [18] 0 0
Change of Albumin (ALB) from Baseline [Safety]
Timepoint [18] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [19] 0 0
Change of Alanine aminotransferase (ALT) from Baseline [Safety]
Timepoint [19] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [20] 0 0
Change of Aspartate aminotransferase (AST) from Baseline [Safety]
Timepoint [20] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [21] 0 0
Change of Alkaline phosphatase (ALP/AKP) from Baseline [Safety]
Timepoint [21] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [22] 0 0
Change of Total bilirubin from Baseline [Safety]
Timepoint [22] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [23] 0 0
Change of Direct bilirubin from Baseline [Safety]
Timepoint [23] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [24] 0 0
Change of Indirect bilirubin from Baseline [Safety]
Timepoint [24] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [25] 0 0
Change of Glutamyl transpeptidase from Baseline [Safety]
Timepoint [25] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [26] 0 0
Change of Blood glucose from Baseline [Safety]
Timepoint [26] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [27] 0 0
Change of Urea from Baseline [Safety]
Timepoint [27] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [28] 0 0
Change of Uric acid from Baseline [Safety]
Timepoint [28] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [29] 0 0
Change of Creatinine from Baseline [Safety]
Timepoint [29] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [30] 0 0
Change of Creatinine Kinase from Baseline [Safety]
Timepoint [30] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [31] 0 0
Change of Total Cholesterol from Baseline [Safety]
Timepoint [31] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [32] 0 0
Change of Triglycerides from Baseline [Safety]
Timepoint [32] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [33] 0 0
Change of Potassium, Sodium, Chloride or Calcium from Baseline [Safety]
Timepoint [33] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [34] 0 0
Change of Leukocyte Count from Baseline [Safety]
Timepoint [34] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [35] 0 0
Change of Neutrophil Count from Baseline [Safety]
Timepoint [35] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [36] 0 0
Change of Percentage of Neutrophil from Baseline [Safety]
Timepoint [36] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [37] 0 0
Change of Lymphocyte Count from Baseline [Safety]
Timepoint [37] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [38] 0 0
Change of Percentage of Lymphocyte from Baseline [Safety]
Timepoint [38] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [39] 0 0
Change of Monocytes Count from Baseline [Safety]
Timepoint [39] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [40] 0 0
Change of Percentage of Monocytes from Baseline [Safety]
Timepoint [40] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [41] 0 0
Change of Eosinophils Count from Baseline [Safety]
Timepoint [41] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [42] 0 0
Change of Percentage of Eosinophils from Baseline [Safety]
Timepoint [42] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [43] 0 0
Change of Basophil Count from Baseline [Safety]
Timepoint [43] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [44] 0 0
Change of Percentage of Basophil from Baseline [Safety]
Timepoint [44] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [45] 0 0
Change of Erythrocyte Count from Baseline [Safety]
Timepoint [45] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [46] 0 0
Change of Hemoglobin from Baseline [Safety]
Timepoint [46] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [47] 0 0
Change of Hematocrit Platelets from Baseline [Safety]
Timepoint [47] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [48] 0 0
Change of Coagulation test-Activated partial thromboplastin time (APTT) from Baseline [Safety]
Timepoint [48] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [49] 0 0
Change of Coagulation test-Prothrombin time (PT) from Baseline [Safety]
Timepoint [49] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [50] 0 0
Change of Coagulation test-Fibrinogen(FIB) from Baseline [Safety]
Timepoint [50] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [51] 0 0
Change of Coagulation test-Thrombin time (TT) from Baseline [Safety]
Timepoint [51] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [52] 0 0
Change of Urine pH from Baseline [Safety]
Timepoint [52] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [53] 0 0
Change of Specific gravity of urine from Baseline [Safety]
Timepoint [53] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [54] 0 0
Change in Occult blood result from Baseline [Safety]
Timepoint [54] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [55] 0 0
Change in Urine Bilirubin result from Baseline [Safety]
Timepoint [55] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [56] 0 0
Change in Urine protein from Baseline [Safety]
Timepoint [56] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [57] 0 0
Change in Urine Glucose from Baseline [Safety]
Timepoint [57] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [58] 0 0
Change in Ketones from Baseline [Safety]
Timepoint [58] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [59] 0 0
Change in Urobilinogen from Baseline [Safety]
Timepoint [59] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [60] 0 0
Change in Urinary leukocyte from Baseline [Safety]
Timepoint [60] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [61] 0 0
Change in Urine erythrocytes from Baseline [Safety]
Timepoint [61] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [62] 0 0
Change in Urine Nitrites from Baseline [Safety]
Timepoint [62] 0 0
On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Primary outcome [63] 0 0
Clinically significant abnormality in physical examinations
Timepoint [63] 0 0
On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 5, each cycle is 21 days.
Secondary outcome [2] 0 0
Time of maximum plasma concentration (Tmax)
Timepoint [2] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Timepoint [3] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-t) of KF-0210
Timepoint [4] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Secondary outcome [5] 0 0
Terminal half-life (T1/2) of KF-0210
Timepoint [5] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Secondary outcome [6] 0 0
Accumulation ratio (Rac)
Timepoint [6] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Secondary outcome [7] 0 0
Cmin to Cmax fluctuation between dose time and Tau (DF)
Timepoint [7] 0 0
Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Secondary outcome [8] 0 0
Blood cytokines/chemokines levels
Timepoint [8] 0 0
Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Secondary outcome [9] 0 0
Urine prostaglandin metabolites level
Timepoint [9] 0 0
Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Secondary outcome [10] 0 0
Tumor T cell infiltration
Timepoint [10] 0 0
Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Secondary outcome [11] 0 0
Change in tumor size from baseline
Timepoint [11] 0 0
From screening through the last dose of treatment, each cycle is 21 days.
Secondary outcome [12] 0 0
Objective response rate (ORR)
Timepoint [12] 0 0
From screening through the last dose of treatment, each cycle is 21 days.
Secondary outcome [13] 0 0
Duration of response (DOR) (days)
Timepoint [13] 0 0
From screening through the last dose of treatment, each cycle is 21 days.
Secondary outcome [14] 0 0
Disease control rate (DCR)
Timepoint [14] 0 0
From screening through the last dose of treatment, each cycle is 21 days.
Secondary outcome [15] 0 0
Progression free survival (PFS)
Timepoint [15] 0 0
From screening through the last dose of treatment, each cycle is 21 days.

Eligibility
Key inclusion criteria
1. Age = 18 years old, male and female;
2. Patients are confirmed by available pathology records or current biopsy having advanced, nonresectable, or recurrent and progressing solid tumors since last anti-tumor therapy, and who are unavailable or intolerable for available standard therapy or there is no standard available therapy.

* Phase Ia (Dose Escalation): Advanced solid tumors;
* Phase Ib (Expansion Study): Patients must have any of the following tumor type and have not participated in Phase Ia trial of this study: CRC (MSS), LC, SCCE, GC, and BC. Among them, patients with LC, SCCE, or GC must have undergone PD-1/PD-L1 treatment for at least 12 weeks and failed.
3. Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans or MRI no longer than 4 weeks before signing ICF);
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Life expectancy= 3 months;
6. Females must not be lactating or pregnant at screening or baseline (negative pregnant test).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with prior anti-tumor therapy within 4 weeks prior to first dosing of KF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);
2. Patients with prior definitive radiation therapy within 6 weeks prior to first dosing of KF-0210, and the irradiated lesions showed no signs of progression if it to be considered target lesions. Or patients with prior palliative radiotherapy within 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related side effects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;
3. Patients who have another active malignancy which is likely to require treatment;
4. Patients who have known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
5. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation);
6. Patients with any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy. Patients with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study;
7. Patients with inflammatory bowel disease or digestive tract diseases (e.g. peptic ulcer disease, including stomach and duodenal ulcer, gastritis and enteritis);
8. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of KF-0210;
9. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids except inhaled or intranasal corticosteroids (with minimal systemic absorption);
10. Current use of NSAIDs, COX-1/COX-2 inhibitors within 4 weeks;
11. Patients who have received surgical or interventional treatment (excluding tumor biopsy, puncture, etc.) within 28 days prior to first dosing of KF-0210;
12. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) prior to the first dosing of KF-0210;
13. Use of any live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dosing of KF-0210;
14. Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade 1 at the time of starting study treatment with exception of alopecia;
15. Any uncontrolled or severe illness, including but not limited to: ongoing or active infection requiring parenteral antibiotics;
16. Positive screening tests for any one of them: human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg); hepatitis B core antibody (HBcAb) (negative for HBsAg, but HBcAb positive, an HBV-DNA test will be performed and if positive will be excluded), hepatitis C antibody (anti-HCV positive, but negative HCV RNA test is allowed to be included).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/04/2023
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Limited - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Keythera Pharmaceuticals (Australia) Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rasha Cosman, MD
Address 0 0
Scientia Clinical Research Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaomei Wang, MS
Address 0 0
Country 0 0
Phone 0 0
+86-18662116821
Fax 0 0
Email 0 0
xiaomei.wang@keytherapharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04713891