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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
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
388
Start Date
2026-10-31
Completion Date
2029-03-30
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
GDC-7035
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Panitumumab
Participants will receive panitumumab in accordance with the local prescribing information.
mFOLFOX6
Participants will receive mFOLFOX6 in accordance with the local prescribing information.
FOLFIRI
Participants will receive FOLFIRI in accordance with the local prescribing information.
mFOLFIRINOX
Participants will receive mFOLFIRINOX in accordance with the local prescribing information.
Gem-nabP
Participants will receive Gem-nabP in accordance with the local prescribing information.