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

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NCT07746141 · readout in 773 d

Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.

Phase

Phase 1

Status

Not yet recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

100estimated

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-09-04

estimated

When the study began enrolling

Primary completion

2028-09-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-09-30

estimated

The whole study's end, after follow-up

First posted

2026-08-04

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-04

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

RAS Mutation
Advanced Solid Tumor
Metastatic Solid Tumor

Interventions

Drug: BG-85738
Drug: Tislelizumab
Drug: Cetuximab

Primary outcomes

what the primary-completion date above is the date OF

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

measured 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)

measured 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

measured Up to approximately 1 month

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

measured Up to approximately 1 month

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

measured Up to approximately 24 months

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

measured Up to approximately 24 months

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