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Monoclonal Antibodies

GS-2121 + Zimberelimab for Cancer

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Tissue requirements: Pretreatment tumor tissue is required for Parts A-D; Participants in Parts A and C backfill cohorts must agree to fresh pre- and on-treatment biopsies

Must not have

Known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD)

Diagnosis of immunodeficiency, either primary or acquired

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to day 21

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and dosage of GS-2121 alone and with zimberelimab in patients with advanced solid tumors. The study will focus on evaluating how well the drugs are

Who is the study for?

This trial is for adults with advanced solid tumors who are eligible to receive new treatments. Specific eligibility criteria aren't provided, but typically participants must have measurable disease and adequate organ function, and cannot be receiving other cancer therapies.

What is being tested?

The study is testing GS-2121 alone or combined with zimberelimab (ZIM) in patients with advanced solid tumors. It aims to determine the safety, tolerability, and optimal dosing of these treatments.

What are the potential side effects?

While specific side effects are not listed, common ones for cancer immunotherapy like GS-2121 and ZIM may include fatigue, skin reactions, flu-like symptoms, allergic reactions, and potential autoimmune responses.

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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I agree to provide tumor tissue samples before and during treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active brain metastases or leptomeningeal disease.

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I have been diagnosed with an immune system disorder.

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I have an ongoing serious infection that needs strong medication.

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I haven't had any cancer treatment within the specified time before starting the study.

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I have had a transplant of tissue or an organ from another person.

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I have an autoimmune disease but haven't needed systemic treatment for it in the last 2 years.

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I have another type of cancer that is currently active.

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I have had lung inflammation treated with steroids.

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I need treatment for fluid buildup in my abdomen or chest.

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I have active hepatitis B, hepatitis C, or HIV.

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I have a serious heart condition or recently had a heart attack.

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I am not on any medications that are not allowed in the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs) During Dose Escalation

Part C: Percentage of Participants with DLTs During Dose Escalation

Secondary study objectives

Parts A and B: PK Parameter: AUC0-24 of GS-2121

Parts A and B: PK Parameter: Cmax of GS-2121

Parts A and B: PK Parameter: Tmax of GS-2121

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D: Combination Dose Expansion of GS-2121 with ZimberelimabExperimental Treatment2 Interventions

Participants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab.

Group II: Part C: Combination Dose Escalation of GS-2121 with ZimberelimabExperimental Treatment2 Interventions

Participants will receive escalating doses of GS-2121 in combination with zimberelimab until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.

Group III: Part B: GS-2121 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion.

Group IV: Part A: GS-2121 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of GS-2121 monotherapy until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2019

Completed Phase 2

~300

0 / 14Eligibility criteria met