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Virus Therapy

Zimberelimab for Solid Cancers

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 and post dose up to 60 day follow-up (up to 24 months)
Awards & highlights

Study Summary

This trial will investigate the safety and tolerability of a new drug for people with solid tumors, and determine the safest dosage.

Who is the study for?
Adults with advanced solid tumors who have tried all other treatments without success or can't tolerate them are eligible for this trial. They must be physically capable of daily activities (ECOG status 0 or 1), have measurable disease, proper organ function, and agree to use contraception if applicable. Those with autoimmune diseases, active second cancers, CNS metastases, significant heart issues, serious infections including HIV/HBV/HCV, lung conditions like pneumonitis, symptomatic fluid accumulation in the body cavities, recent vaccinations or pregnancy are excluded.Check my eligibility
What is being tested?
The study is testing GS-4528 alone and combined with an Anti-PD-1 Monoclonal Antibody to see if they're safe and tolerable for treating solid tumors. It aims to find the highest dose patients can take without severe side effects (MTD/MAD) and recommend a Phase 2 dose (RP2D).See study design
What are the potential side effects?
Potential side effects include immune system reactions that could affect various organs leading to inflammation-related symptoms; these may range from mild discomforts such as fatigue to more serious conditions requiring medical attention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 and post dose up to 60 day follow-up (up to 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 and post dose up to 60 day follow-up (up to 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerable Dose (MTD) of GS-4528
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Percentage of Participants who Develop Antidrug Antibody (ADA) Against GS-4528
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)Experimental Treatment2 Interventions
Participants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy.
Group II: Phase 1a: GS-4528 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase.
Group III: Phase 1a: GS-4528 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,130 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,561 Total Patients Enrolled

Media Library

GS-4528 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05840224 — Phase 1
Solid Tumors Research Study Groups: Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab), Phase 1a: GS-4528 Monotherapy Dose Escalation, Phase 1a: GS-4528 Monotherapy Dose Expansion
Solid Tumors Clinical Trial 2023: GS-4528 Highlights & Side Effects. Trial Name: NCT05840224 — Phase 1
GS-4528 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05840224 — Phase 1

Frequently Asked Questions

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

Is this clinical examination open to enrolment at the moment?

"According to the information posted on clinicaltrials.gov, as of June 1st 2023 this experiment continues to actively recruit participants. The trial was initially announced on May 11th 2023."

Answered by AI

What is the uppermost limit of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov data confirms that this investigation, which was initially posted on May 11th 2023, is actively recruiting for 132 participants from a single medical facility."

Answered by AI

Has the FDA given approval for Phase 1a: GS-4528 Monotherapy Dose Escalation?

"Due to a lack of prior clinical data, our team at Power assigned the safety of Phase 1a: GS-4528 Monotherapy Dose Escalation with a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of GS-4528 in Adults With Solid Tumors
2023. "Study of GS-4528 in Adults With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05840224.
~84 spots leftby Dec 2025
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