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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06074497




Registration number
NCT06074497
Ethics application status
Date submitted
3/10/2023
Date registered
10/10/2023
Date last updated
10/10/2023

Titles & IDs
Public title
A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation Trial of KGX101 Administered as a Monotherapy to Patients With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
KGX101ST101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KGX101- Cohort 1
Treatment: Drugs - KGX101- Cohort 2
Treatment: Drugs - KGX101- Cohort 3
Treatment: Drugs - KGX101- Cohort 4
Treatment: Drugs - KGX101- Cohort 5
Treatment: Drugs - KGX101- Cohort 6
Treatment: Drugs - KGX101- Cohort 7
Treatment: Drugs - KGX101- Cohort 8

Experimental: KGX101- Cohort 1 - Dosage level: Dose level 1 Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 2 - Dosage level: Dose level 2. Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 3 - Dosage level: Dose level 3 Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 4 - Dosage level: Dose level 4 Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 5 - Dosage level: Dose level 5 Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 6 - Dosage level: Dose level 6 Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 7 - Dosage level: Dose level 7 Dose form: White-like lyophilized powder Route of administration: Intravenous

Experimental: KGX101- Cohort 8 - Dosage level: Dose level 8 Dose form: White-like lyophilized powder Route of administration: Intravenous


Treatment: Drugs: KGX101- Cohort 1
Single dose of 0.003 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 2
Single dose of 0.006 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 3
Single dose of 0.012 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 4
Single dose of 0.025 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 5
Single dose of 0.05 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 6
Single dose of 0.1 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 7
Single dose of 0.2 mg/kg of KGX101 every 3 weeks

Treatment: Drugs: KGX101- Cohort 8
Single dose of 0.3 mg/kg of KGX101 every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Treatment emergent Adverse events (TEAEs)
Timepoint [1] 0 0
From baseline to 30 days after the last dose administration.
Primary outcome [2] 0 0
Number of participants with Dose Limiting Toxicities (DLTs) at week 4
Timepoint [2] 0 0
From Day1 after the first dose of KGX101 full treatment to D28 post dose.
Secondary outcome [1] 0 0
PK Parameters: Maximum Concentration (Cmax) K Parameters: Maximum Concentration (Cmax) PK Parameters: Maximum Concentration (Cmax)
Timepoint [1] 0 0
Dose escalation- From pre-dose of the first dose of KGX101 full treatment to 336 hours after the first and 4th dose of full treatment.
Secondary outcome [2] 0 0
PK Parameters: Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
Dose escalation- From pre-dose of the first dose of KGX101 full treatment to 336 hours after the first dose of full treatment. In addtion, pre-dose of other KGX101 treatment will be also collected.
Secondary outcome [3] 0 0
PK Parameters: Area under the curve (AUC)
Timepoint [3] 0 0
Dose escalation- From pre-dose of the first dose of KGX101 full treatment to 336 hours after the first dose of full treatment. In addtion, pre-dose of other KGX101 treatment will be also collected.
Secondary outcome [4] 0 0
PK Parameters: Half- life (T1 /2)
Timepoint [4] 0 0
Dose escalation- From pre-dose of the first dose of KGX101 full treatment to 336 hours after the first dose of full treatment. In addtion, pre-dose of other KGX101 treatment will be also collected.
Secondary outcome [5] 0 0
PK Parameters- Trough concentration (Ctrough)
Timepoint [5] 0 0
Dose escalation- From pre-dose of the first dose of KGX101 full treatment to 336 hours after the first dose of full treatment. In addtion, pre-dose of other KGX101 treatment will be also collected.
Secondary outcome [6] 0 0
PK Parameters- Systemic clearance (CL)
Timepoint [6] 0 0
Dose escalation- From pre-dose of the first dose of KGX101 full treatment to 336 hours after the first dose of full treatment. In addtion, pre-dose of other KGX101 treatment will be also collected.
Secondary outcome [7] 0 0
Immunogenicity- Anti-drug antibody (ADA)
Timepoint [7] 0 0
Cohort 1-2: Day1 pre-dose and Day22 pre-dose; Cohort 3-8: Pre-dose of every dose, Day 15 post the first full treatment of KGX101 dose and Day 14 post the last dose.

Eligibility
Key inclusion criteria
1. Any histologically or cytologically confirmed solid tumor malignancy that is locally
advanced or metastatic and has failed standard therapy, standard therapy does not
confer survival benefit, or standard therapy is not available.

2. Age at least 18 years.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.

4. Has at least 1 measurable lesion per RECIST 1.1 (lesions situated in a previously
irradiated area are considered measurable if progression has been demonstrated in such
lesions).

5. Has adequate organ and bone marrow function as per the study.

6. Willingness of men and women of reproductive potential to observe highly effective
birth control for the duration of treatment and for 3 months following the last dose
of study drug.

7. Archival tumor tissue available or provide a fresh tumor biopsy.

8. Life expectancy of approximately 3 months or longer in the opinion of the
Investigator.

9. Provision of signed and dated written informed consent prior to any study-specific
procedures, sampling, and analyses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A history of another active malignancy (i.e., a second cancer) within the previous 2
years, except for localized cancers that are not related to the current cancer being
treated, are considered cured, and, in the opinion of the Investigator, present a low
risk of recurrence. These exceptions include but are not limited to basal or squamous
cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate,
cervix, or breast.

2. Patients with primary CNS malignancies;

3. A history of allogeneic tissue/solid organ transplant.

4. Any evidence of severe or uncontrolled systemic diseases, including:

1. Active, uncontrolled systemic bacterial, viral, or fungal infection;

2. uncontrolled hypertension (Systolic blood pressure more than equal to 160mHG or
diastolic blod pressure more than equal to 100mm HG or poor compliance with
anti-hypertensive agents;

3. or active bleeding diatheses;

4. Clinically significant arrhythmia, unstable angina pectoris, congestive heart
failure (class III or IV of New York Heart Association [NYHA]) or acute
myocardial infarction within 6 months;

5. Uncontrolled diabetes or poor compliance with hypoglycemic agents;

6. The presence of chronically unhealed wound or ulcers;

7. Other chronic diseases, which, in the opinion of the Investigator, could
compromise safety of the patient or the integrity of study.

5. Active autoimmune disease requiring systemic treatment in the past 2 years.

6. Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving
chronic systemic or enteric steroid therapy.

7. A history of (non-infectious) pneumonitis / interstitial lung disease that required
steroids or has current pneumonitis / interstitial lung disease.

8. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric
Castleman Disease.

9. Active infection as determined by hepatitis B surface antigen and hepatitis B core
antigen antibody, or hepatitis B virus DNA by quantitative polymerase chain reaction
(qPCR) testing.

10. Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCR
testing.

11. Major surgery (excluding placement of vascular access) within 4 weeks prior to the
first dose of study drug.

12. Treatment with any of the following:

1. Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug,
intratumoral, etc.);

2. Presence of CNS metastases that are symptomatic and/or require local CNS directed
therapy (such as XRT or surgery) or increasing doses of corticosteroids within 2
weeks prior to the first dose of study drug. Except patients with treated brain
metastases should be neurologically stable and receiving less than equal to 10mg
per day of prednisone or equivalent prior to study entry;

3. Investigational agent or anticancer therapy (including chemotherapy, biologic
therapy, immunotherapy, anticancer Chinese medicine, or anticancer herbal remedy)
within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of
study drug;

4. Radiotherapy within 2 weeks of the start of study treatment. A 1-week washout is
permitted for palliative radiation (less than equal to two weeks of radiotherapy)
to non-CNS disease;

5. Received a live or live-attenuated vaccine within 30 days of the first dose of
study drug; Note: Administration of killed vaccines or other formats are allowed;

6. Diagnosis of immunodeficiency, on immunosuppressive therapy, or receiving chronic
systemic or enteric steroid therapy (dose > 10 mg/day of prednisone or
equivalent);

7. Prior receipt of an allogeneic stem cell transplant or allogeneic CAR-T cell
therapy;

13. Any unresolved toxicities from prior therapy greater than NCI CTCAE version 5.0 Grade
1 at the time of starting study drug with the exception of alopecia and Grade 2 prior
platinum-therapy related neuropathy.

14. Significant electrocardiogram (ECG) abnormalities.

15. Any illness, medical condition, organ system dysfunction, or social situation
(including mental illness or substance abuse), that may interfere with a patient's
ability to sign the ICF, adversely affect the patient's ability to cooperate and
participate in the study, or compromise interpretation of study results.

16. Pregnant (confirmed by serum beta human chorionic gonadotropin [ HCG]) or lactating.

17. History of hypersensitivity to any of the study drug components.

18. Participant is known or suspected of not being able to comply with the study protocol
(e.g. because of alcoholism, drug dependency, or psychological disorder) or the
participant has any condition for which, in the opinion of the Investigator,
participation would not be in the best interest of the participant (e.g. compromise
their well-being) or that could prevent, limit, or confound the protocol-specified
assessments.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
2/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/09/2026
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [2] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3199 - Frankston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kangabio AUSTRALIA LTD PTY
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a first-in-human, multicenter, Phase 1, open-label, dose-escalation study designed to
evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),
immunogenicity, and preliminary efficacy of KGX101, a tumor-activated interleukin 12 prodrug,
as monotherapy in patients with advanced or metastatic solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06074497
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Weidong Jiang, Dr
Address 0 0
Chief Executive Officer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yi Zhao
Address 0 0
Country 0 0
Phone 0 0
+86 18019087115
Fax 0 0
Email 0 0
yzhao@kangabio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06074497