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2024-11-26
2026-12
2026-12
177
NCT06585488
BeiGene
BeiGene
INTERVENTIONAL
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
This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-09-03 | N/A | 2025-05-02 |
2024-09-03 | N/A | 2025-05-06 |
2024-09-05 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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. | DRUG: BGB-53038
|
| 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. | DRUG: BGB-53038
|
| 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. | DRUG: BGB-53038
DRUG: Tislelizumab
DRUG: Cetuximab
|
| EXPERIMENTAL: Phase 1b: Part D (Monotherapy Dose Expansion) Participants will be enrolled to receive the RDFE(s) of BGB-53038 monotherapy | DRUG: BGB-53038
|
| 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. | DRUG: BGB-53038
DRUG: Tislelizumab
DRUG: Cetuximab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Phase 1a: Number of Participants Experiencing Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCICTCAE] Version [v] 5.0), timing, seriousness, and relationship to study drug(s); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria | Up to approximately 2 years |
| Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038 | defined as the highest dose at which 30% of the participants experienced a DLT or the highest dose administered, respectively. | Up to approximately 2 years |
| Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-53038 | The potential RDFE(s) of BGB-53038 as monotherapy or in combination with other antitumor therapies (tislelizumab or cetuximab) will be determined based on the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available. | Up to approximately 2 years |
| Phase 1b: Overall Response Rate (ORR) | ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1 | Up to approximately 2 years |
| Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-53038 | The RP2D of BGB-53038 as monotherapy or in combination with other antitumor therapies (tislelizumab or cetuximab) will be determined based on safety, long-term tolerability, PK, preliminary antitumor activity, and any other relevant data, as available | Up to approximately 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Phase 1a: Single-dose and steady-state area under the concentration-time curve (AUC) of BGB-53038 | Up to approximately 2 years | |
| Phase 1a: Single-dose and steady-state Half-life (t1/2) of BGB-53038 | Up to approximately 2 years | |
| Phase 1a: Single-dose and steady-state maximum observed plasma concentration (Cmax) of BGB-53038 | Up to approximately 2 years | |
| Phase 1a: Single-dose and steady-state trough concentration (Ctrough) of BGB-53038 | Up to approximately 2 years | |
| Phase 1b: ORR | ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1. | Up to approximately 2 years |
| Duration of Response (DOR) | DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. | Up to approximately 2 years |
| Time to Response (TRR) | defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) lasting ≥ 24 weeks as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
| Progression Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. | Up to approximately 2 years |
| Phase 1b: Overall Survival (OS) | defined as the time from the date of first dose of study drug until the date of death from any cause | Up to approximately 2 years |
| Phase 1b: Number of Participants Experiencing Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the NCI-CTCAE v5.0), timing, seriousness, and relationship to study drug(s) | Up to approximately 2 years |
| Plasma concentrations of BGB-53038 | Up to approximately 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Study Director Phone Number: 1.877.828.5568 Email: clinicaltrials@beigene.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
