Not Yet RecruitingPhase 1

A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations

100 participantsStarted 2026-09-04

Plain-language summary

The purpose of this study is to test if the BG-85738 is safe and if it works in patients with advanced solid tumors with RAS mutations when it is given on its own and in combination.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1My tumor has a RAS mutation — is this the specific type of RAS mutation that this trial is designed to target, and would my biopsy results make me a potential candidate worth discussing with the research team?
2Since this is a first-in-human Phase 1 trial that hasn't started enrolling yet, what does that mean for what's currently known about BG-85738's safety profile, and how does that level of uncertainty compare to my standard treatment options?
3The trial is focused on finding the right dose and identifying serious side effects — given that dose-limiting toxicities are being actively studied, what kinds of risks should I be prepared to discuss if this trial eventually opens and we consider whether it fits my situation?
4This trial isn't recruiting yet — do you know roughly when it might open, and is it worth waiting for it versus starting another treatment now given where my cancer stands?
5The trial includes both a monotherapy arm and combination arms with other antitumor agents — if this eventually became an option for me, which arm might be most relevant to my cancer type, and how would that affect what side effects I'd need to watch for?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1a (Part A and Part B): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 24 months

Phase 1a (Parts A and B): Number of Participants with Dose Limiting Toxicity (DLT)

Timeframe: Up to approximately 1 month

Phase 1a (Parts A and B): Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-85738 as monotherapy or in combination with other antitumor agents

Timeframe: Up to approximately 1 month

Phase 1a: Recommended Dose for Expansion (RDFE) of BG-85738

Timeframe: Up to approximately 1 month

Part 1b (Parts C and D): Overall Response Rate (ORR)

Timeframe: Up to approximately 24 months

Phase 1b Dose Expansion: Recommended Phase 2 dose (RP2D) of BG-85738

Timeframe: Up to approximately 24 months

Trial details

NCT IDNCT07746141

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Study Director

877-828-5568 clinicaltrials@beonemed.com

View on ClinicalTrials.gov More RAS Mutation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phase 1a (Part A and Part B): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 24 months

Phase 1a (Parts A and B): Number of Participants with Dose Limiting Toxicity (DLT)

Timeframe: Up to approximately 1 month

Phase 1a (Parts A and B): Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-85738 as monotherapy or in combination with other antitumor agents

Timeframe: Up to approximately 1 month

Phase 1a: Recommended Dose for Expansion (RDFE) of BG-85738

Timeframe: Up to approximately 1 month

Part 1b (Parts C and D): Overall Response Rate (ORR)

Timeframe: Up to approximately 24 months

Phase 1b Dose Expansion: Recommended Phase 2 dose (RP2D) of BG-85738

Timeframe: Up to approximately 24 months