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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
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Cancer -
Solid Tumors
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Study Identifier
NCT07905924, BP46586, 2026-526415-11-00
Condition
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
Study 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.
Eligibility Criteria
All
≥18 Years
No
Inclusion Criteria
- Participants with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 assessed by the Investigator
- Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- Life expectancy ≥12 weeks, as determined by the Investigator
- Presence of KRAS, neuroblastoma RAS viral oncogene homolog (NRAS) or Harvey rat sarcoma viral oncogene homolog (HRAS) G12V mutation in blood or tumor tissue previously determined by a local assay at any time prior to Screening
- Consent to provide archival tumor tissue, if available
Exclusion Criteria
- Known hypersensitivity or medical contraindication to any component of the RO7836748 formulation
- Inability or unwillingness to swallow pills
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
- Inability to comply with study and follow-up procedures
- Participants with chronic diarrhea, short bowel syndrome or significant upper GI surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including, but not limited to, peptic ulcer disease, and diverticulitis).
- Known and untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- Participants with any leptomeningeal disease
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com