GDC-1971 + Atezolizumab for Advanced Solid Cancers

No longer recruiting at 43 trial locations

Overseen By GO43712 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Disqualifiers: CNS metastases, Liver disease, Autoimmune disease, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with advanced solid tumors, such as certain types of lung cancer, head and neck cancer, and melanoma. The study aims to assess the safety and behavior of the treatment in the body when combining GDC-1971 (also known as RLY-1971) with atezolizumab, an existing cancer drug. Participants will take GDC-1971 orally and receive atezolizumab through an IV to monitor side effects and potential benefits. Those who have not succeeded with standard treatments or for whom standard treatments are unsuitable might be well-suited for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

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

The trial protocol does not specify if you need to stop your current medications. However, since the trial involves new treatments, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

Will I have to stop taking my current medications?

The trial information does not specify if 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 this trial's treatments are likely to be safe?

Research shows that atezolizumab is usually well-tolerated, meaning most people can handle it without serious problems. Studies have found no new safety concerns when combined with other treatments for advanced cancers. This suggests it might also be safe with GDC-1971, although limited information exists about GDC-1971 alone. Since this trial is in an early stage, the main goal is to find the safest dose of GDC-1971 and monitor any side effects. Researchers continue to learn how people react to this combination. Participants might experience side effects, but the trial is designed to carefully monitor and manage them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of GDC-1971 and atezolizumab for advanced solid cancers because of its unique approach to treatment. Unlike standard treatments that primarily focus on directly killing cancer cells with chemotherapy, this combo leverages the body’s own immune system. Atezolizumab is an immunotherapy that blocks the PD-L1 protein, helping to unleash an immune response against cancer cells, while GDC-1971 is designed to enhance this immune response further. Together, they aim to improve effectiveness and potentially overcome resistance seen with other treatments. Additionally, the study explores different formulations and the impact of food and acid-reducing agents, which could lead to more personalized and convenient treatment options.

What evidence suggests that this trial's treatments could be effective for advanced solid cancers?

Research shows that atezolizumab, one of the treatments in this trial, effectively treats some types of cancer. In patients with non-small cell lung cancer (NSCLC) who have high levels of the protein PD-L1, atezolizumab significantly improved survival rates compared to traditional chemotherapy. Those who received the treatment over a long period experienced notably longer average survival times. GDC-1971, another treatment option in this trial, blocks a protein that helps cancer cells grow. Although still under study, combining it with drugs like atezolizumab appears promising due to its mechanism of action. Together, these drugs could offer a strong approach to treating advanced cancers. ^{6 7 8 9 10}

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 certain advanced solid tumors, including specific types of lung cancer, head and neck cancer, and melanoma. Participants should be in good physical condition (ECOG 0 or 1), have a life expectancy of at least 12 weeks, no prior treatments for their advanced cancer, and meet specific genetic markers like PD-L1 positivity.

Inclusion Criteria

My head or neck cancer is PD-L1 positive and has returned or spread, with no prior treatments.

My organs are working well.

Has Life expectancy >= 12 weeks

Exclusion Criteria

My high blood pressure is not under control.

My heart's pumping ability is below normal or less than 50%.

I have brain metastases that are untreated or getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-finding Stage

Participants receive GDC-1971 orally and atezolizumab IV infusion to determine the appropriate dose

21 days per cycle

1 visit every 3 weeks

Expansion Stage

Participants with specific cancer types receive GDC-1971 and atezolizumab to evaluate safety and activity

21 days per cycle

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• GDC-1971
• Omeprazole

Trial Overview The study tests GDC-1971 combined with Atezolizumab to assess safety and effectiveness against various advanced solid tumors. It has two parts: finding the right dose and then expanding to more patients with different tumor types based on PD-L1 levels or BRAF status.

How Is the Trial Designed?

Group I: Expansion Stage: GDC-1971 Experimental Treatment 3 Interventions

Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971.

Group II: Dose-finding Stage: GDC-1971 Experimental Treatment 2 Interventions

Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

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

Published Research Related to This Trial

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab, an anti-PD-L1 monoclonal antibody, has shown durable responses in treating locally advanced and metastatic urothelial cancer, especially in patients who have failed platinum-based chemotherapy or are ineligible for cisplatin.

The treatment with atezolizumab has a more favorable toxicity profile compared to traditional cytotoxic chemotherapy, making it a promising option for patients with advanced bladder cancer, although further research is needed to identify additional predictive markers for response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab in invasive and metastatic urothelial carcinoma. Crist, M., Balar, A.[2019]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Atezolizumab, an immune checkpoint inhibitor, has been shown to significantly prolong overall survival in patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy, based on results from the phase II POPLAR and phase III OAK trials.

The treatment is particularly effective in patients with higher PD-L1 expression, demonstrating higher objective response rates, and it has a manageable safety profile with a low incidence of immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer. Blair, HA.[2020]

Citations

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