NCT06619587 A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
| NCT ID | NCT06619587 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Genentech, Inc. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2024-11-14 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 410 participants in total. It began in 2024-11-14 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Reference Study ID Number: GO45416 https://forpatients.roche.com/
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S.)
Clinical Trials
STUDY DIRECTOR
Hoffmann-La Roche
Frequently Asked Questions
Who can join the NCT06619587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06619587 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06619587 currently recruiting?
Yes, NCT06619587 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT06619587 trial being conducted?
This trial is being conducted at La Jolla, United States, Denver, United States, New Haven, United States, Lake Mary, United States and 11 additional locations.
Who is sponsoring the NCT06619587 clinical trial?
NCT06619587 is sponsored by Genentech, Inc.. The principal investigator is Clinical Trials at Hoffmann-La Roche. The trial plans to enroll 410 participants.