> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-safety-pharmacokinetics-and-activity-of-eabf3054-7a4b-4bb0-85cb-14873aa51775 > Record changed: 2026-10-13 # A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors NCT06619587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) Participants 410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) Start date 2024-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) Number of sites 42 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Title and summary **Summary** This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Short title** A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Official title** A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Dates **Completion date** 2028-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **First posted** 2024-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Primary completion date** 2028-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Start date** 2024-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Size and sites **Participants** 410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Planned participants** 410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Number of sites** 42 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Identifiers **Registry ID** NCT06619587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **ClinicalTrials.gov ID** NCT06619587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Outcomes ### Primary outcomes 1. Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale Timeframe: 4 Years 2. Percentage of Participants with Dose Limiting Toxicity Timeframe: 4 Years ### Secondary outcomes 1. Plasma Concentrations of GDC-7035 at Specified Timepoints Timeframe: 4 Years 2. Blood Concentrations of GDC-7035 at Specified Timepoints Timeframe: 4 Years 3. Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal Timeframe: 4 Years 4. Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal Timeframe: 4 Years 5. Objective Response Rate Among Participants Timeframe: 4 Years 6. Duration of Response Among Participants Timeframe: 4 Years 7. Median Progression Free Survival Time Among Participants Timeframe: 4 Years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation - Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm ### Exclusion criteria - Malabsorption or other condition that would interfere with enteral absorption - Active brain metastases - Clinically significant cardiovascular dysfunction or liver disease Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Sites - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - Florida Cancer Specialist-Lake MaryLake Mary, United StatesCompleted - University of IllinoisChicago, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - START - Midwest - EDOSGrand Rapids, United StatesRecruiting - Montefiore Einstein Cancer CenterThe Bronx, United StatesRecruiting - Mary Crowley Medical Research CenterDallas, United StatesRecruiting - Abramson Cancer Center;Univ of PennsylvaniaPhiladelphia, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - O'Quinn Medical Tower at McNair CampusHouston, United StatesRecruiting - St Vincent's Hospital SydneyDarlinghurst, AustraliaRecruiting - Slade Health Inward goodsMount Kuring-Gai, AustraliaRecruiting - Peter Maccallum Cancer CentreParkville, AustraliaRecruiting - British Columbia Cancer AgencyVancouver, CanadaRecruiting - Princess Margaret Cancer CentreToronto, CanadaRecruiting - Sir Mortimer B Davis Jewish General HospitalMontreal, CanadaRecruiting - Gustave RoussyVillejuif, FranceRecruiting - Institut BergonieBordeaux, FranceRecruiting - Centre Georges Francois LeclercDijon, FranceRecruiting - Rambam Health Care CampusHaifa, IsraelRecruiting - Hadassah University Hospital - Ein KeremJerusalem, IsraelRecruiting - The Chaim Sheba Medical CenterRamat Gan, IsraelRecruiting - Tel Aviv Sourasky Medical Center PPDSTel Aviv, IsraelRecruiting And 17 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06619587) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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