Terminated

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID06585488

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

Led by BeOne Medicines · Updated on 2026-06-03

47

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  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).
Not Eligible

You will not qualify if you...

  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.

Trial Site Locations

Total: 17 locations

1

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, United States, 90089-1019

Status Unknown

2

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States, 66160-8500

Status Unknown

3

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland, United States, 21287

Status Unknown

4

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States, 77030-4009

Status Unknown

5

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

Status Unknown

6

Monash Health

Clayton, Victoria, Australia, VIC 3168

Status Unknown

7

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

Status Unknown

8

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

Status Unknown

9

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Status Unknown

10

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Status Unknown

11

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China, 030013

Status Unknown

12

Auckland City Hospital

Auckland, New Zealand, 1023

Status Unknown

13

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Status Unknown

14

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea, 06351

Status Unknown

15

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Status Unknown

16

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Status Unknown

17

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea, 05505

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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