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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

Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Histologically confirmed recurrent, or metastatic HNSCC with PD-L1 positive and no prior systemic therapy (Expansion Stage: HNSCC Cohort)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2.5 years

Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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

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My advanced lung cancer is PD-L1 positive and lacks EGFR and ALK mutations.

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My melanoma is advanced, not removable by surgery, and has worsened after anti PD1/PD-L1 therapy.

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My advanced cancer has not responded to or I cannot tolerate standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2.5 years

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

567,457 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,270 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper-limit for enrollment in this experiment?

"Affirmative. As indicated by data hosted on clinicaltrials.gov, this research trial is actively seeking out new participants with a goal of 232 patients from 3 separate medical facilities. The original posting date was August 17th 2022 and the latest update took place November 22nd 2022."

Answered by AI

Has the FDA endorsed GDC-1971 for use?

"The safety of GDC-1971 has been assessed at 1 due to the limited evidence associated with its efficacy and security, as it is still in Phase 1."

Answered by AI

Is registration available for this clinical investigation?

"Affirmative. Per clinicaltrials.gov, recruitment for this trial is in progress and has been since August 17th 2022. Last updated on November 22nd 2022, the study requires 232 patients to be enrolled across 3 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

2022. "A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487235.