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NCT07859085
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
Conditions: Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 388
Sponsor: Genentech, Inc.
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Malabsorption syndrome or other conditions that would interfere with enteral absorption
* Known and untreated, or active central nervous system (CNS) metastases
* Known clinically significant liver disease
* History of or active clinically significant cardiovascular dysfunction
Other protocol-defined inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07859085). StuddyBuddy aggregates publicly available trial information.