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Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 18 and up

BG-85738 alone or with other anticancer drugs in RAS-mutant advanced or metastatic solid tumors

Official title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-85738, Alone or in Combination With Other Antitumor Agents, in Patients With Advanced or Metastatic Solid Tumors With RAS Mutations

Run by BeOne Medicines · NCT07746141 · Data updated 2026-11-12

This study tests BG-85738, alone or with other cancer drugs, in adults whose solid tumors have RAS mutations and have progressed.

More Advanced Solid Tumor trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorBeOne Medicines
Industry-sponsored
Locations3 sites (South Brisbane, Queensland and 2 other locations)
StatusRecruiting
StartedSeptember 2, 2026
Main results expectedSeptember 30, 2028
Study endsSeptember 30, 2028
Registry record updatedOctober 23, 2026
Trial IDNCT07746141 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with histologically or cytologically confirmed advanced or metastatic solid tumors and a documented RAS mutation (KRAS, NRAS, or HRAS at specified codons).

Probably not a fit

Patients without a RAS mutation or whose tumors do not respond to BG-85738 or combinations may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial has two parts: dose escalation to find a safe, recommended dose of BG-85738, followed by a safety expansion to further evaluate its effects. It examines BG-85738 as a single agent and in combination with other antitumor medicines for adults with advanced or metastatic solid tumors that harbor RAS mutations. The study will enroll participants at multiple centers worldwide, with careful monitoring for safety and preliminary signals of activity. Interventions include BG-85738 alone or together with tislelizumab or cetuximab. Eligible patients are adults with confirmed RAS-mutant, unresectable tumors and adequate organ function.

Why it matters

Potential benefit: If successful, BG-85738 could offer a new treatment option for patients whose tumors have RAS mutations and have limited choices.

How similar studies have gone: RAS-targeted therapies in this space have shown mixed results; this first-in-human study explores a novel approach in a well-defined mutation subset.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants are eligible to be included in the study only if they meet all the following criteria:

* Participants must sign the informed consent form and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older), at the time of signing the ICF.
* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors and meet study part and cohort-specific criteria
* Participants must have evidence of a RAS mutation defined as a nonsynonymous mutation in Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), or Harvey rat sarcoma viral oncogene homolog (HRAS) at codons 12, 13, or 61 (G12, G13, or Q61), based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by the local laboratory

Exclusion Criteria:

Participants are excluded from the study if they meet any of the following criteria:

* Participants who have prior RAS-targeted therapy, including, but not limited to, KRAS mutation-specific inhibitors (with the exception of participants with NSCLC and colorectal cancer who received a G12C inhibitor), pan-KRAS inhibitors, and pan-RAS inhibitors.
* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment.
* Participants who are unable to comply with the requirements of the protocol.
* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastases
* Participants with any malignancy ≤ 3 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
* Participants with active hepatitis C.
* Participants with medical history of untreated Human Immunodeficiency Virus infection.

Note: Other protocol defined criteria may apply.

Where it's running

  • Icon Cancer Centre South Brisbane
    South Brisbane, Queensland, Australia     Recruiting
  • Cabrini Hospital Malvern
    Malvern, Victoria, Australia     Recruiting
  • Auckland City Hospital
    Auckland, New Zealand     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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RAS Mutation 11Advanced Solid Tumor 230Metastatic Solid Tumor 50BeOne Medicines 40
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.