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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05006794
Other study ID # GS-US-467-5643
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 15, 2021
Est. completion date January 2027

Study information

Verified date June 2024
Source Gilead Sciences
Contact Gilead Clinical Study Information Center
Phone 1-833-445-3230 (GILEAD-0)
Email GileadClinicalTrials@gilead.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase I open-label, multi-center study of GS-9716 tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose of GS-9716, and characterize the safety and tolerability of GS-9716 as monotherapy and in combination with anti-cancer therapies.


Recruitment information / eligibility

Status Recruiting
Enrollment 195
Est. completion date January 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: General Inclusion Criteria (all cohorts): - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease per RECIST version 1.1 - Adequate hematology, renal and hepatic function - Left ventricular ejection fraction (LVEF) = 50% - Patients with brain metastases may be enrolled only if treated, nonprogressive, asymptomatic and not taking high dose steroids for at least 4 weeks prior to Cycle 1 Day 1 (C1D1) - Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception, per protocol. - Tissue criteria: must provide sufficient, and adequate tumor tissue sample or agree to have a biopsy taken. Part A Specific Inclusion Criteria: GS-9716 as monotherapy - 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. Cohorts B1 and C1 Specific Inclusion Criteria: - Histologically or cytologically confirmed unresectable metastatic or locally advanced disease following treatment for metastatic disease including an immune checkpoint inhibitor and a platinum-containing chemotherapy - Patients with actionable genomic alterations must have also received treatment with at least 1 approved therapy appropriate to the genomic alteration unless unavailable or contraindicated Cohorts B4 and C4 Specific Inclusion Criteria: - Histologically or cytologically confirmed disease based on the most recent analyzed biopsy metastatic disease that is refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens, one of which was a taxane (unless contraindicated). Key Exclusion Criteria: - Prior systemic anti-cancer therapy must meet wash-out criteria outlined in protocol - Treatment with any high dose systemic corticosteroids or nonsystemic radiotherapy within 2 weeks of the first dose of GS-9716 (low dose corticosteroids permitted). - Women who are pregnant or lactating - Patients with active = Grade 2 nausea or vomiting, and/or signs of intestinal obstruction - Known active or chronic hepatitis B or C infection or HIV infection/ HIV positive - Known history of clinically significant cardiovascular disease or heart failure. - Known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory illness present within 6 months prior to C1D1 - Known history of other clinically significant pulmonary disease or evidence of active pneumonitis - Uncontrolled pleural effusion, pericardial effusion, or ascites - History of clinically significant bleeding, intestinal obstruction, or gastrointestinal (GI) perforation within 6 months prior to C1D1 - Infection requiring intravenous anti-infective use within 2 weeks prior to C1D1 - Active or history of autoimmune disease or immune deficiency - History of uncured coexisting cancer, not including uncured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer. Cohort A Specific Exclusion Criteria: GS-9716 as monotherapy: - Known heart failure or elevated cardiac biomarkers Cohorts B1 and C1 Specific Exclusion Criteria: - Known hypersensitivity to excipients in study treatments. Cohorts B4 and C4 Specific Exclusion Criteria: - Prior treatment with sacituzumab govitecan-hziy or a topoisomerase 1 inhibitor or agents targeting Trop-2. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GS-9716
Tablet(s) administered orally
Docetaxel
Administered intravenously
sacituzumab govitecan-hziy
Administered intravenously

Locations

Country Name City State
Israel Rambam Health Care Campus Haifa
Israel Hadassah Medical Center- Ein Kerem Jerusalem
Israel Tel-Aviv Sourasky Medical Center Tel Aviv
United States University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Aurora Colorado
United States Montefiore Medial Center - Montefiore Medical Park Bronx New York
United States START Midwest Grand Rapids Michigan
United States Sarah Cannon Research Institute Nashville Tennessee
United States Oregon Health Oregon Health & Sciences University-Knight Cancer Institute Portland Oregon
United States START San Antonio San Antonio Texas
United States Moffitt Cancer Center Tampa Florida
United States START Mountain Region West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs) First dose date up to 21 days
Primary Percentage of Patients Experiencing Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 First dose date up to last dose date (Maximum: 105 weeks) plus 30 days
Secondary Maximum Observed Concentration (Cmax) for GS-9716 Approximately 105 Weeks
Secondary Time to Maximum Observed Concentration (Tmax) for GS-9716 Approximately 105 Weeks
Secondary Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for GS-9716 Approximately 105 Weeks
Secondary Parts B and C: Objective Response Rate (ORR) ORR is defined as the percentage of patients who achieve a confirmed complete response (CR) or confirmed partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Up to 105 weeks
Secondary Parts B and C: Disease Control Rate (DCR) DCR is defined as the percentage of patients who achieve a CR, PR, or stable disease (SD) as assessed by RECIST version 1.1. Up to 105 weeks
Secondary Parts B and C: Progression-Free Survival (PFS) PFS is defined as the interval from the first dose of GS-9716 to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause. First dose date to PD or death, whichever occurs first (up to 39 months)
Secondary Parts B and C: Time to Response (TTR) TTR is defined as the time from first dose of GS-9716 to the first documentation of CR or PR. First dose date to the first documentation of CR or PR (up to 105 weeks)
Secondary Parts B and C: Duration of Response (DOR) DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. From first documentation of CR or PR to PD or death, whichever occurs first (up to 37 months)
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