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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07859085). StuddyBuddy aggregates publicly available trial information.