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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06585488




Registration number
NCT06585488
Ethics application status
Date submitted
3/09/2024
Date registered
5/09/2024

Titles & IDs
Public title
A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
Scientific title
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplifications
Secondary ID [1] 0 0
2024-514704-13-00
Secondary ID [2] 0 0
BGB-53038-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Solid Tumors 0 0
Advanced Non-squamous Non-small-cell Lung Cancer 0 0
Advanced Colorectal Cancer 0 0
Advanced Pancreatic Ductal Adenocarcinoma 0 0
Advanced Gastric Cancer 0 0
Advanced Gastroesophageal Junction Cancer 0 0
Advanced Esophageal Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-53038
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Cetuximab

Experimental: Phase 1a: Part A (Monotherapy Dose Escalation) - Sequential cohorts will be evaluated to determine the Recommended Dose for Expansion (RDFE) of BGB-53038 as a monotherapy.

Experimental: Phase 1a: Part B (Monotherapy Safety Expansion) - Participants will be enrolled at dose levels determined in Part A with the Safety Monitoring Committee to confirm the final RDFE(s) for BGB-53038 monotherapy.

Experimental: Phase 1a: Part C (Combination Therapy Dose Escalation) - Sequential cohorts with increasing doses will be evaluated to determine the RDFE(s) for BGB-53038 in combination with tislelizumab or cetuximab.

Experimental: Phase 1b: Part D (Monotherapy Dose Expansion) - Participants will be enrolled to receive the RDFE(s) of BGB-53038 monotherapy

Experimental: Phase 1b: Part E (Combination Therapy Dose Expansion) - Participants will be enrolled to receive BGB-53038 at the RDFE(s) as determined in Part C of Phase 1a in combination with tislelizumab and in combination with cetuximab, respectively.


Treatment: Drugs: BGB-53038
Administered orally

Treatment: Drugs: Tislelizumab
administered by intravenous infusion

Treatment: Drugs: Cetuximab
administered by intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-53038
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-53038
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: Single-dose and steady-state area under the concentration-time curve (AUC) of BGB-53038
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Phase 1a: Single-dose and steady-state Half-life (t1/2) of BGB-53038
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Phase 1a: Single-dose and steady-state maximum observed plasma concentration (Cmax) of BGB-53038
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Phase 1a: Single-dose and steady-state trough concentration (Ctrough) of BGB-53038
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Phase 1b: ORR
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Time to Response (TRR)
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Disease Control Rate (DCR)
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Progression Free Survival (PFS)
Timepoint [9] 0 0
Up to approximately 2 years
Secondary outcome [10] 0 0
Phase 1b: Overall Survival (OS)
Timepoint [10] 0 0
Up to approximately 2 years
Secondary outcome [11] 0 0
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Timepoint [11] 0 0
Up to approximately 2 years
Secondary outcome [12] 0 0
Plasma concentrations of BGB-53038
Timepoint [12] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
1. Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
3. Participants must have evidence of a KRAS mutation or wild-type amplification (copy number = 8) based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by local laboratory
4. Able to provide an archived tumor tissue sample or fresh biopsy sample.
5. = 1 measurable lesion per RECIST v1.1.
6. Adequate organ function.
7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, for > 7 days after the last dose of BGB-53038, > 120 days after the last dose of tislelizumab, or > 2 months after the last dose of cetuximab, whichever is later
8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for = 4 months after the last dose of study drug(s).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants with tumors harboring KRAS G12R mutation.
2. Participants who have prior therapy with other anti-RAS treatment, including, but not limited to, therapy targeting specific KRAS allele mutation inhibitors, pan-KRAS inhibitors, and other pan-RAS inhibitors
3. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable CNS metastases are eligible, provided they meet select criteria.
4. Any malignancy = 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
5. Participants with untreated chronic hepatitis B or chronic HBV carriers with HBV DNA = 500 IU/mL (or = 2500 copies/mL) at screening. Participants with active hepatitis C.
6. Participants with clinically significant infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy = 14 days before the first dose of study treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
177
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Shanxi
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT06585488