> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-and-activity-of-gdc-7035-with-7d38495b-884e-43b7-9a7b-393ac86bf581 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) Participants 388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) Start date 2026-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Dates **Completion date** 2029-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **First posted** 2026-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Primary completion date** 2029-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Start date** 2026-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Size and sites **Participants** 388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Planned participants** 388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Identifiers **Registry ID** NCT07859085 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **ClinicalTrials.gov ID** NCT07859085 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Outcomes ### Primary outcomes 1. Number of Participants With Adverse Events (AEs) Timeframe: Up to approximately 30 months 2. Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs) Timeframe: Up to Day 28 ### Secondary outcomes 1. Objective Response Rate (ORR) Timeframe: Up to approximately 30 months 2. Duration of Response (DOR) Timeframe: Up to approximately 30 months 3. Progression-free Survival (PFS) After Randomization Timeframe: Up to approximately 30 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers - 2026-525460-17-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07859085) ## Related records ### Drugs (5) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin calcium](https://trialight.com/data/asset/leucovorin-calcium-8da292ca-1b92-4365-b525-77d897b1c096.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Panitumumab](https://trialight.com/data/asset/panitumumab-ea8dc0f1-ea1f-4586-b6ad-68fc23ba56f1.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Conditions (2) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) Primary condition - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) ### Targets (3) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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