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GS-9716 + Anticancer Therapies for Advanced 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
Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor for which no standard therapy is available, standard therapy has failed, or for whom standard-of-care therapy is contraindicated
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date to pd or death, whichever occurs first (up to 39 months)
Awards & highlights

Study Summary

This trial is studying the side effects of a new drug called GS-9716 when given alone or with other drugs to treat patients with solid tumors that have spread to other parts of the body.

Who is the study for?
Adults with advanced solid tumors who have tried at least one standard treatment or for whom no standard treatment is suitable. They must be in fairly good physical condition (ECOG status of 0 or 1), have a certain level of heart, kidney, and liver function, and cannot have untreated brain metastases or serious health conditions like active hepatitis B/C or autoimmune diseases.Check my eligibility
What is being tested?
GS-9716 is being tested alone and alongside other cancer drugs to find the highest dose patients can take without severe side effects. The trial will also look at how well GS-9716 works as a single agent versus when combined with established cancer treatments in people with various types of solid tumors.See study design
What are the potential side effects?
Since this is an early-phase trial to determine safety, specific side effects are not listed but may include typical reactions to cancer therapies such as nausea, fatigue, blood count changes, potential organ inflammation, allergic reactions to the drug infusion, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has no standard treatment available, or standard treatments have failed.
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I am fully active or can carry out light work.
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My cancer has returned or didn't respond after 2 treatments, including a taxane.
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My advanced cancer was confirmed by a lab test and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date to pd or death, whichever occurs first (up to 39 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date to pd or death, whichever occurs first (up to 39 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
Percentage of Patients Experiencing Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for GS-9716
Maximum Observed Concentration (Cmax) for GS-9716
Parts B and C: Disease Control Rate (DCR)
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part C (Cohort C4): GS-9716 + sacituzumab govitecan-hziyExperimental Treatment2 Interventions
Patients will receive ≤ MTD GS-9716 in combination with sacituzumab govitecan-hziy.
Group II: Part C (Cohort C1): GS-9716 + docetaxelExperimental Treatment2 Interventions
Patients will receive ≤ MTD GS-9716 in combination with docetaxel.
Group III: Part B (Cohort B4): GS-9716 + sacituzumab govitecan-hziyExperimental Treatment2 Interventions
Patients will receive escalating doses of GS-9716 in combination with sacituzumab govitecan-hziy.
Group IV: Part B (Cohort B1): GS-9716 + docetaxelExperimental Treatment2 Interventions
Patients will receive escalating doses of GS-9716 in combination with docetaxel.
Group V: Part A: GS-9716 Dose-ExpansionExperimental Treatment1 Intervention
Patients will receive ≤ MTD of GS-9716.
Group VI: Part A: GS-9716 Dose-EscalationExperimental Treatment1 Intervention
Patients will receive escalating doses of GS-9716 to estimate MTD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,284 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,498 Total Patients Enrolled

Media Library

GS-9716 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05006794 — Phase 1
Solid Tumors Research Study Groups: Part A: GS-9716 Dose-Expansion, Part B (Cohort B4): GS-9716 + sacituzumab govitecan-hziy, Part A: GS-9716 Dose-Escalation, Part B (Cohort B1): GS-9716 + docetaxel, Part C (Cohort C1): GS-9716 + docetaxel, Part C (Cohort C4): GS-9716 + sacituzumab govitecan-hziy
Solid Tumors Clinical Trial 2023: GS-9716 Highlights & Side Effects. Trial Name: NCT05006794 — Phase 1
GS-9716 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006794 — Phase 1

Frequently Asked Questions

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

Are there still opportunities for prospective participants in this trial?

"Confirmed. According to information on clinicaltrials.gov, this trial is currently enrolling participants with the original post date of September 15th 2021 and a recent update from November 10th 2022. There are 5 sites recruiting over 200 patients in total."

Answered by AI

Has GS-9716 been accorded official sanction by the FDA?

"The safety of GS-9716 is appraised as a 1 since this Phase 1 trial has only collected limited proof for its efficacy and security."

Answered by AI

What have been the other research endeavors associated with GS-9716?

"Presently, 752 clinical trials are actively underway for GS-9716 with 247 of these in their final phase. Most of the studies have been set up at a location within Woolloongabba, Queensland yet there exists an expansive network of 42846 sites conducting research on this therapeutic agent."

Answered by AI

For what conditions has GS-9716 demonstrated effectiveness?

"GS-9716 is a viable therapeutic option for neoplasm metastasis, as well as metastatic bladder cancer, advance directives, and urinary bladder."

Answered by AI

How many participants does this research involve?

"Gilead Sciences, the trial's sponsor, will be recruiting 205 appropriately qualified patients from START Mountain Region in Grand Rapids and START San Antonio in Texas."

Answered by AI

How many settings is this experiment supervised in?

"START Mountain Region in Grand Rapids, Michigan, START San Antonio in San Antonio, Texas and START Midwest in Portland Oregon are a few centres recruiting participants for this medical research. Additionally, there are 5 other clinical sites participating."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
2021. "Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006794.
~99 spots leftby Jan 2027
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