GDC-1971 + Atezolizumab for Advanced Solid Cancers

Recruiting at 33 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

232 Participants Needed

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.

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.

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 data supports the effectiveness of the drug Atezolizumab for advanced solid cancers?

Atezolizumab has shown effectiveness in treating various cancers, including bladder cancer and non-small cell lung cancer, by blocking a protein that helps cancer cells hide from the immune system. In clinical trials, it improved survival rates and had a favorable safety profile, making it a promising option for patients with advanced cancers. ^{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}

What safety data exists for Atezolizumab (Tecentriq) in humans?

Atezolizumab (Tecentriq) has been shown to have an acceptable safety profile in clinical trials for various cancers, including non-small cell lung cancer and bladder cancer. Common side effects include fatigue, decreased appetite, and nausea, while more serious but less common effects include pneumonia and liver inflammation. Overall, it is considered to have a manageable safety profile. ^{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}

What makes the drug GDC-1971 + Atezolizumab unique for advanced solid cancers?

The combination of GDC-1971 and Atezolizumab is unique because it combines a novel investigational drug (GDC-1971) with Atezolizumab, a monoclonal antibody that blocks PD-L1, enhancing the immune system's ability to attack cancer cells. This approach aims to improve treatment outcomes by targeting the immune system in a way that is different from traditional chemotherapy. ^{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.

Timeline

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

Treatment Details

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.

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.

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

Findings from Research

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, 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 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, 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]

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]

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]