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NOT YET RECRUITING
NCT07905924
PHASE1

A Study to Evaluate the Safety and Effectiveness of Different Doses of RO7836748 Alone or in Combination With Other Cancer Therapies in People With Solid Tumors With a Rat Sarcoma Viral Oncogene Homolog Glycine 12 Valine (RAS G12V) Mutation

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of RO7836748 as monotherapy and in combination with other anti-cancer therapies, including cetuximab, pembrolizumab, or modified (m)FOLFIRINOX in participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V-positive solid tumors such as non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC), and other solid tumors.

Official title: A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7836748 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Participants With Advanced Solid Tumors With a RAS G12V Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

540

Start Date

2026-12-31

Completion Date

2032-03-30

Last Updated

2026-10-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

RO7836748

Participants will receive RO7836748 as per the schedule described in the protocol.

DRUG

Pembrolizumab

Participants will receive pembrolizumab as per the schedule described in the protocol.

DRUG

mFOLFIRINOX

Participants will receive mFOLFIRINOX as per the schedule described in the protocol.

DRUG

Cetuximab

Participants will receive cetuximab as per the schedule described in the protocol.