GDC-1971 + Atezolizumab for Advanced Solid Cancers

Recruiting in Fairfax (>99 mi)

+33 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, GDC-1971, combined with an existing treatment, atezolizumab, in patients with advanced or spreading solid tumors. It includes specific cancers like certain lung cancers, head and neck cancers, and melanoma. The goal is to see if this combination can better help the immune system find and destroy cancer cells. Atezolizumab is an immune checkpoint inhibitor that has shown efficacy in combination with other treatments for various cancers.

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.

What data supports the idea that GDC-1971 + Atezolizumab for Advanced Solid Cancers is an effective drug?

The available research shows that Atezolizumab, when used alone, has shown effectiveness in treating advanced bladder cancer and non-small cell lung cancer. For bladder cancer, it improved survival rates and had a favorable safety profile. In lung cancer, it extended survival compared to another drug, docetaxel. However, there is no specific data provided on the combination of GDC-1971 and Atezolizumab for advanced solid cancers, so we can't directly assess its effectiveness from the information given. ^{1 2 3 4 5}

What safety data is available for the treatment with GDC-1971 and Atezolizumab?

Atezolizumab, also known as Tecentriq, has been evaluated in several clinical trials for different types of cancer, including non-small cell lung cancer (NSCLC), urothelial carcinoma, and bladder cancer. The safety profile of Atezolizumab has been deemed acceptable, with common adverse reactions including fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation. More severe grade 3 to 4 adverse events include dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, and liver enzyme increases. Immune-related adverse events such as pneumonitis, hepatitis, colitis, and thyroid disease have been observed in a small percentage of patients. The safety data for GDC-1971 specifically is not detailed in the provided research, but Atezolizumab's safety profile is well-documented across multiple studies. ^{1 2 3 5 6}

Is the drug Atezolizumab, used in the trial GDC-1971 + Atezolizumab for Advanced Solid Cancers, a promising treatment?

Yes, Atezolizumab is a promising drug because it has shown to improve survival rates and has been approved for treating certain advanced cancers like bladder and lung cancer. It works by boosting the body's immune response against tumors, leading to better outcomes for patients. ^{1 3 4 6 7}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• GDC-1971 (Other)
• Omeprazole (Other)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Duarte, CA

Ottawa Hospital Ottawa, Canada

Cross Cancer Institute Edmonton, Canada

Princess Margaret Cancer Centre Toronto, Canada

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1578

Patients Recruited

569,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, 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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]

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

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. [2019]

5. France pubmed.ncbi.nlm.nih.gov

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

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

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Atezolizumab in invasive and metastatic urothelial carcinoma. [2019]