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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

RECRUITINGPhase 1Sponsored by BeOne Medicines
Actively Recruiting
PhasePhase 1
SponsorBeOne Medicines
Started2026-09-02
Est. completion2028-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07746141

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

Advanced Solid TumorCancerMetastatic Solid TumorRAS Mutation

Interventions3

BG-85738CetuximabTislelizumab

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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