NCT07905924Not yet recruitingPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 31 Dec 2026
- Primary completion date
- 30 Mar 2032
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Sarcoma
- NCT number
- NCT07905924
- EU CT number
- 2026-526415-11-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 540
- From 31 Dec 2026 to the primary completion date, 30 Mar 2032
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
- Known and untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Other illness
- Known hypersensitivity or medical contraindication to any component of the RO7836748 formulation
- 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).
- Participants with any leptomeningeal disease
Other
- Inability or unwillingness to swallow pills
- Inability to comply with study and follow-up procedures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.