A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06619587

Enrollment

410

Registered

2024-10-01

Start date

2024-11-14

Completion date

2028-05-31

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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.

Interventions

DRUGPhase I Arm A

Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035

DRUGPhase I Arm B

Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale	4 Years
Percentage of Participants with Dose Limiting Toxicity	4 Years

Secondary

Measure	Time frame
Plasma Concentrations of GDC-7035 at Specified Timepoints	4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints	4 Years
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal	4 Years
Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal	4 Years
Objective Response Rate Among Participants	4 Years
Duration of Response Among Participants	4 Years
Median Progression Free Survival Time Among Participants	4 Years

Countries

Australia, Canada, France, Israel, Italy, Singapore, South Korea, Spain, United Kingdom, United States

Contacts

CONTACTReference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below.

global-roche-genentech-trials@gene.com888-662-6728 (U.S.)

CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026