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Monoclonal Antibodies

GDC-1971 + Atezolizumab for Advanced Solid Cancers

Phase 1
Recruiting
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 approximately 2.5 years
Awards & highlights

Summary

This trial will study the safety and efficacy of GDC-1971 in combination with atezolizumab in people with locally advanced or metastatic solid tumors. There will be two stages to the trial- a dose-finding stage and an expansion stage. In the expansion stage, participants with NSCLC PD-L1 high, NSCLC PD-L1 low, HNSCC PD-L1 positive, BRAF WT melanoma, and any other locally advanced or metastatic solid tumors will be enrolled.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Percentage of Participants With Adverse Events (AEs)
Electrocardiogram
+3 more
Secondary outcome measures
Omeprazole
AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
+10 more

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
~5860

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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Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,542 Previous Clinical Trials
567,845 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
890,074 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
~70 spots leftby May 2025