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GS-1811 + Zimberelimab for Solid Tumors

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
Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit
Individuals with pathologically confirmed select advanced solid tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to end of treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Awards & highlights

Study Summary

This trial will help to find the best dose of GS-1811 to give to patients with advanced solid tumors, either alone or in combination with Zimberelimab.

Who is the study for?
Adults with advanced solid tumors who've tried all other treatments without success or can't tolerate them are eligible. They must have measurable disease, be in fair to good physical condition (ECOG 0-2), and agree to use contraception. Tissue samples for testing are required.Check my eligibility
What is being tested?
The trial is assessing GS-1811 alone or combined with Zimberelimab to find the safest and most effective doses for treating advanced solid tumors. It's divided into parts: some test GS-1811 solo, others in combination therapy.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, as seen with similar drugs like inflammation of organs or tissues, fatigue, infection risks, and possibly infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an advanced solid tumor and cannot take or have tried all known beneficial treatments.
Select...
I have been diagnosed with a specific advanced solid tumor.
Select...
I have an advanced solid tumor and cannot take or have tried all known beneficial treatments.
Select...
I have tried or cannot take all known beneficial treatments for my condition.
Select...
I have an advanced solid tumor and cannot take or have tried all known beneficial treatments.
Select...
I can care for myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to end of treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to end of treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days 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 Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR) in Part D
+7 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part F: GS-1811 Monotherapy and In Combination With Zimberelimab In Select Dose and ScheduleExperimental Treatment2 Interventions
Group II: Part E: GS-1811 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Group III: Part D: GS-1811 + Zimberelimab Dose ExpansionExperimental Treatment2 Interventions
Group IV: Part C: GS-1811 + Zimberelimab Dose EscalationExperimental Treatment2 Interventions
Group V: Part B - Mandatory Paired Tumor BiopsyExperimental Treatment1 Intervention
Group VI: Part A - GS-1811 Dose EscalationExperimental Treatment1 Intervention
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
1,083 Previous Clinical Trials
842,983 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,317 Total Patients Enrolled

Media Library

GS-1811 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05007782 — Phase 1
Solid Tumors Research Study Groups: Part F: GS-1811 Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule, Part D: GS-1811 + Zimberelimab Dose Expansion, Part C: GS-1811 + Zimberelimab Dose Escalation, Part A - GS-1811 Dose Escalation, Part B - Mandatory Paired Tumor Biopsy, Part E: GS-1811 Monotherapy Dose Expansion
Solid Tumors Clinical Trial 2023: GS-1811 Highlights & Side Effects. Trial Name: NCT05007782 — Phase 1
GS-1811 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05007782 — Phase 1

Frequently Asked Questions

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

What other research initiatives involving GS-1811 have been conducted thus far?

"Currently, the clinical trial landscape for GS-1811 encompasses a total of 961 active trials with 122 at Phase 3. Houston is an epicentre for this research, yet there are 35731 other sites currently running studies related to GS-1811."

Answered by AI

Has the FDA ratified GS-1811 for therapeutic use?

"Our internal assessment at Power rated GS-1811's safety as a 1, indicating there is limited evidence to back the drug's efficacy and security."

Answered by AI

How many individuals are eligible to participate in this trial?

"Affirmative. Clinicaltrials.gov verifies that the trial is presently recruiting applicants, with its original posting on 8/18/2021 and last amendment taking place 11/2/202. The study requires 158 participants from nine distinct sites to complete it."

Answered by AI

Are there any ongoing opportunities to join this trial?

"Affirmative, the clinicaltrials.gov website displays that this investigation is currently searching for participants and has been since August 18th 2021. The most recent alterations to the trial's data were made on November 2nd 2022 with a total of 158 patients being recruited from 9 sites."

Answered by AI

In what geographical areas is this investigation being conducted?

"Nine medical facilities are taking part in this clinical trial, with Beth Israel Deaconess Medical Center in Boston, WCG IRB in La Jolla, and Stanford Cancer Center in Palo Alto being the most prominent. Additionally, there are 6 other locations providing their services to the study."

Answered by AI

What ailments has GS-1811 been shown to mitigate?

"GS-1811 is usually used to treat malignant neoplasms, yet also has been found effective in treating other conditions like unresectable melanoma and microsatellite instability high. Additionally, GS-1811 may help patients who have had their disease progress after chemotherapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
2021. "Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05007782.
~216 spots leftby Dec 2027
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