GDC-7035 for Cancer

Recruiting at 38 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GDC-7035 for individuals with advanced or metastatic solid tumors that have a specific genetic change known as the KRAS G12D mutation. Researchers aim to determine the treatment's safety and effectiveness, both alone and in combination with other cancer therapies. The trial includes different groups to assess various doses of the treatment. Suitable candidates for this trial have been diagnosed with advanced solid tumor cancer carrying this specific gene mutation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that GDC-7035 is likely to be safe for humans?

Research shows that GDC-7035 is a new treatment currently being tested for safety in humans. This Phase 1 study marks the first time GDC-7035 is being tried in people. The main goal is to determine if it is safe and well-tolerated.

The safety of GDC-7035 remains under investigation, so the researchers have not yet determined how well people handle the treatment. In Phase 1 trials, researchers focus on identifying any side effects and determining the appropriate dose. These trials typically involve a small number of participants.

Prospective participants should be aware that side effects are possible, as with any new treatment. However, the trial is designed to closely monitor participants for any negative effects and ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often include chemotherapy and radiation, GDC-7035 is unique because it targets cancer cells with precision. This drug works by honing in on specific molecular pathways that cancer cells rely on to grow, which could potentially reduce damage to healthy cells compared to traditional treatments. Researchers are excited about GDC-7035 because it offers a new mechanism of action that may improve treatment outcomes and minimize side effects, providing hope for more effective and gentler cancer therapies.

What evidence suggests that GDC-7035 might be an effective treatment for cancer?

Research has shown that drugs targeting the KRAS G12D mutation, such as GDC-7035, hold promise because this mutation promotes cancer growth. In this trial, researchers are studying GDC-7035 in two separate arms, both involving dose escalation and expansion. GDC-7035 is combined with gemcitabine, a drug effective in treating some advanced cancers, including breast cancer and non-small cell lung cancer. Early studies suggest that RAS inhibitors, which contribute to GDC-7035's mechanism, can be effective against various cancer types, although resistance may develop over time. These factors indicate that GDC-7035 could effectively treat cancers with the KRAS G12D mutation. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06619587

NCT06619587 | A Study to Evaluate Safety, ... A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors.

2. withpower.com withpower.com/trial/phase-2-tumors-solid-9-2024-95910

GDC-7035 for Cancer · Recruiting Participants for Phase ... The research shows that combinations involving gemcitabine, a component of GDC-7035, have been effective in treating advanced breast cancer and non-small cell ...

3. trial.medpath.com trial.medpath.com/clinical-trial/b87faf833e90b13f/nct06619587-gdc-7035-kras-g12d-mutation-solid-tumors

A Study to Evaluate Safety, Pharmacokinetics, and Activity of ... A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors. Phase 1.

4. aacrjournals.org aacrjournals.org/cancerdiscovery/article/15/7/1325/763195/Response-and-Resistance-to-RAS-Inhibition-in

Response and Resistance to RAS Inhibition in Cancer RAS inhibitors have shown early evidence of efficacy in multiple cancer types, but clinical benefit is limited by acquired resistance.

5. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/cancer/solid-tumors/a-study-to-evaluate-safety--pharmacokinetics--and-activ-16036.pdf

A Study to Evaluate Safety, Pharmacokinetics, and Activity of ... This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, ...

6. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT06619587/

NCT06619587: A trial that was reported late by Genentech, ... Full data ; A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in ...