What is the mechanism of action of this treatment?

The most common treatments for solid tumors often involve immunotherapy, such as PD-1/PD-L1 inhibitors like Atezolizumab. These treatments work by blocking the interaction between PD-1 receptors on T cells and PD-L1 on tumor cells, preventing the tumor cells from evading the immune system. This allows the immune system to recognize and attack the tumor cells more effectively. Understanding these mechanisms is crucial for patients with solid tumors as it underscores the role of the immune system in combating cancer and the potential benefits of immunotherapy in improving treatment outcomes.

What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly immune checkpoint inhibitors like Atezolizumab, commonly cause immune-related adverse events (irAEs). These include inflammation in organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), hormone glands (endocrinopathies), and skin. Severe side effects can include pulmonary embolism, acute myocardial infarction, and sepsis. Management typically involves withholding the treatment and using immunosuppressive therapies.

What prior FDA approvals exist?

Atezolizumab, a PD-L1 inhibitor, has received FDA approval for various solid tumors, including non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (RCC). Other similar PD-1/PD-L1 inhibitors include Pembrolizumab, approved for NSCLC, melanoma, and esophageal squamous cell carcinoma, and Nivolumab, approved for melanoma and esophageal squamous cell carcinoma. These approvals highlight the efficacy of immune checkpoint inhibitors in treating a range of solid tumors.

What other types of research exist?

Promising alternatives to GDC-1971 and Atezolizumab for solid tumors include: 1) Pembrolizumab (PD-1 Inhibition), which has shown efficacy in various solid tumors including gastric, esophageal, and renal cell carcinoma. 2) Nivolumab (PD-1 Inhibition), effective in non-small cell lung cancer and renal cell carcinoma. 3) Ipilimumab (CTLA-4 Inhibition), often used in combination with Nivolumab for enhanced efficacy. 4) Bevacizumab (VEGF Inhibition), particularly in combination with Atezolizumab for renal cell carcinoma. These alternatives offer different mechanisms of action and have demonstrated clinical benefits in solid tumors.

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Monoclonal Antibodies

GDC-1971 + Atezolizumab for Advanced Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune-related reactions due to Atezolizumab (like inflammation in organs), typical chemotherapy side effects such as fatigue, nausea, liver issues from GDC-1971, plus any additional risks related to combining these drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion Stage: GDC-1971Experimental Treatment3 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-1971Experimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omeprazole

2006

Completed Phase 4

~940

Atezolizumab

2017

Completed Phase 3

~5850

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors often involve immunotherapy, such as PD-1/PD-L1 inhibitors like Atezolizumab. These treatments work by blocking the interaction between PD-1 receptors on T cells and PD-L1 on tumor cells, preventing the tumor cells from evading the immune system. This allows the immune system to recognize and attack the tumor cells more effectively. Understanding these mechanisms is crucial for patients with solid tumors as it underscores the role of the immune system in combating cancer and the potential benefits of immunotherapy in improving treatment outcomes.

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Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,550 Previous Clinical Trials

568,132 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,212 Previous Clinical Trials

892,184 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05487235 — Phase 1

Solid Tumors Research Study Groups: Expansion Stage: GDC-1971, Dose-finding Stage: GDC-1971

Solid Tumors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05487235 — Phase 1

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487235 — Phase 1

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