GDC-7035 for Cancer

Recruiting at 10 trial locations

Overseen By Reference Study ID Number: GO45416 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Disqualifiers: Malabsorption, Brain metastases, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

410 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug GDC-7035 for cancer?

The research shows that combinations involving gemcitabine, a component of GDC-7035, have been effective in treating advanced breast cancer and non-small cell lung cancer, suggesting potential effectiveness for GDC-7035 in cancer treatment. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that have a specific change called the KRAS G12D mutation. Participants must be able to have children and agree to follow strict rules about preventing pregnancy during the study.

Inclusion Criteria

Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

My cancer has a KRAS G12D mutation.

Exclusion Criteria

I do not have conditions affecting my body's ability to absorb medications.

I have serious heart or liver problems.

I have active cancer spread to my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of GDC-7035 to evaluate safety and pharmacokinetics

8-12 weeks

Dose Expansion

Participants receive GDC-7035 at the determined safe dose to further evaluate activity

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• GDC-7035

Trial Overview The study is testing GDC-7035, both alone (Phase I Arm A) and combined with other cancer treatments (Phase I Arm B), in people whose tumors have not responded to standard treatments. It's an early-phase trial focusing on safety and how well it works.

Participant Groups

Group I: Phase I Arm B Experimental Treatment 1 Intervention

Dose escalation and expansion arm

Group II: Phase I Arm A Experimental Treatment 1 Intervention

Dose escalation and expansion arm

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

References

1. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine plus docetaxel versus docetaxel in patients with predominantly human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: a randomized, phase III study by the Danish Breast Cancer Cooperative Group. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A Phase II Study with Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Phase III trial of gemcitabine plus docetaxel versus capecitabine plus docetaxel with planned crossover to the alternate single agent in metastatic breast cancer. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[A clinical study on efficacy of gemcitabine and carboplatin versus paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer]. [2011]