Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Solid Malignancies

Gender

N/A

Date

September 2021 - January 2027

Study Type

Interventional

Study Phase

Phase 1

Product

GS-9716, Docetaxel, sacituzumab govitecan-hziy

Eligibility Information

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).

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.

Locations

Locations (9)

START Midwest

Grand Rapids, Michigan, United States, 49546

Montefiore Medial Center - Montefiore Medical Park

Bronx, New York, United States, 10467

Oregon Health Oregon Health & Sciences University-Knight Cancer Institute

Portland, Oregon, United States, 97239

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

START San Antonio

San Antonio, Texas, United States, 78229

START Mountain Region

West Valley City, Utah, United States, 84119

Rambam Health Care Campus

Haifa, Israel, 31096

Hadassah Medical Center- Ein Kerem

Jerusalem, Israel, 91120

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

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