A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid... | NCT07746141

NCT07746141

Overview

NCT ID: NCT07746141
Lead Sponsor: BeOne MedicinesINDUSTRY
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
Brief 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.
Conditions: RAS Mutation
Advanced Solid Tumor
Metastatic Solid Tumor
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Sep 4, 2026Estimated
Primary Completion Date: Sep 30, 2028Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility 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.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 100Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking

Contacts and Locations

Central Contacts: Study DirectorContact
clinicaltrials@beonemed.com

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Participant Group/Arms

Phase 1a: Part A- Monotherapy Dose escalation and safetyExperimental

Ascending dose levels of BG-85738 will be evaluated as monotherapy in participants with advanced or metastatic solid tumors with RAS mutations.

Drug: BG-85738

Phase 1a: Part B - Combination therapy Dose escalationExperimental

Sequential dose levels of BG-85738, selected based on Part A data, will be evaluated in combination with tislelizumab or in combination with cetuximab.

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Phase 1b: Part C- Monotherapy dose expansionExperimental

Participants with selected tumor types will receive BG-85738 monotherapy at the RDFE(s) identified in Phase 1a Part A.

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Phase 1b: Part D - Combination therapy dose expansionExperimental

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Drug: BG-85738

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