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GS-9911 +/− 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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date up to 90 days post last dose (up to 105 weeks)

Awards & highlights

Study Summary

This trial seeks to learn about the safety and dosing of a drug for advanced solid cancers.

Who is the study for?

Adults with advanced solid tumors who have tried or can't receive other treatments may join. They should be fairly active (ECOG 0-1), have tumors measurable by RECIST v1.1, proper organ function, and agree to provide tissue samples and use contraception if applicable. Excluded are pregnant/lactating women, those with severe reactions to immunotherapy, recent recipients of certain therapies, immune deficiencies or high-dose steroids users, active infections like HBV/HCV/HIV, serious heart conditions or autoimmune diseases.Check my eligibility

What is being tested?

The trial is testing GS-9911 alone and combined with Zimberelimab (anti-PD-1 antibody) in adults with advanced solid tumors. It aims to find the safest dose that can be given without causing too many side effects (MTD/MAD) and decide on a recommended dose for further study (RDE).See study design

What are the potential side effects?

Possible side effects include typical reactions related to immune system activation such as fatigue, skin issues, inflammation in various organs including lungs (pneumonitis), potential worsening of autoimmune conditions if pre-existing ones were mild enough not to exclude participation from the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to 90 days post last dose (up to 105 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to 90 days post last dose (up to 105 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to 90 days post last dose (up to 105 weeks) 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 any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts

Percentage of Participants With Treatment-emergent Adverse Events

Percentage of Participants With Treatment-emergent Serious Adverse Events

Secondary outcome measures

Area Under the Concentration-Time Curve (AUC) of GS-9911

PK Parameter: Tmax of GS-9911

Pharmacokinetic (PK) Parameter: Cmax of GS-9911

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal AntibodyExperimental Treatment2 Interventions

Participants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab).

Group II: Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal AntibodyExperimental Treatment2 Interventions

Participants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab).

Group III: Part B: GS-9911 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A.

Group IV: Part A: GS-9911 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of GS-9911 monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2018

Completed Phase 1

~50

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,359 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,573 Total Patients Enrolled

Frequently Asked Questions

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

What safety thresholds are there for the GS-9911 Monotherapy Dose Escalation protocol?

"The safety of Part A: GS-9911 Monotherapy Dose Escalation was assigned a rating of 1 due to the fact that it is currently being tested in Phase 1, meaning there's limited data regarding efficacy and safety."

Answered by AI

Are there vacancies available for individuals to join this trial?

"Per the information posted on clinicaltrials.gov, this experiment is not presently recruiting patients; having been originally published in October 1st 2023 and last updated on October 20th 2023. Nevertheless, there are 2,776 other medical trials searching for participants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

2023. "Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082960.

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