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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
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
RO7836748
Participants will receive RO7836748 as per the schedule described in the protocol.
Pembrolizumab
Participants will receive pembrolizumab as per the schedule described in the protocol.
mFOLFIRINOX
Participants will receive mFOLFIRINOX as per the schedule described in the protocol.
Cetuximab
Participants will receive cetuximab as per the schedule described in the protocol.