UPCC 05925 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

Investigating the Safety and Effects of an Investigational Medication for Advanced Solid Tumors with a Specific Gene Mutation

Enrolling By Invitation
18 years or above
All
Phase 1
410 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Solid Tumor
  • Age: 18 years or above
  • Gender: All

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

This study investigates the safety and effects of an investigational medication in people with advanced solid tumors that have a specific gene change called KRAS G12D mutation. The purpose of this study is to learn how the investigational medication works when given alone or with other cancer treatments.

Participants in the study will receive the investigational medication either by itself or along with other anti-cancer therapies. Researchers will monitor how the body processes the medication and any side effects that occur. This study will help determine the best dose and gather information on how the medication affects the tumor.

  • Who can participate: Adults with advanced or metastatic solid tumors that have the KRAS G12D mutation may be eligible. Participants must agree to follow contraception guidelines if they can have children or produce sperm. Those with malabsorption issues, active brain metastases, or significant heart or liver disease are not eligible.
  • Study details: Participants will take the investigational medication either alone or with other treatments. Researchers will observe how the medication is processed in the body and monitor for any side effects.
Updated on 28 Jul 2026. Study ID: 25-0422
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator