drugset / Trial / 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

NCT07859085 ↗

Phase 1 Not yet recruiting 388 enrolled Genentech, Inc.
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2026-10-31
Primary completion
2029-03-30
Completion
2029-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject GDC-7035 Unknown — —
Subject Gemcitabine Small molecule — —
Subject Irinotecan Small molecule — —
Subject Leucovorin Small molecule — —
Subject Nab-paclitaxel Small molecule — —
Subject Oxaliplatin Small molecule — —
Subject Panitumumab Monoclonal antibody — —
Subject fluorouracil Small molecule — —