NCT07859085Not yet recruitingPhase 1
A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 388 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 30 Mar 2029
- Lead sponsor
- Genentech, Inc.
- Diseases
- Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07859085
- EU CT number
- 2026-525460-17-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 388
- From 31 Oct 2026 to the primary completion date, 30 Mar 2029
- 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.
Other illness
- Malabsorption syndrome or other conditions that would interfere with enteral absorption
- Known clinically significant liver disease
- History of or active clinically significant cardiovascular dysfunction
- Other protocol-defined inclusion/exclusion criteria may apply.
Other
- Known and untreated, or active central nervous system (CNS) metastases
Who the study is looking for
- Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
- Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
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.