ACTIVE_NOT_RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase I open-label, multi-center study of zamzetoclax (formerly 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 zamzetoclax, and characterize the safety and tolerability of zamzetoclax as monotherapy and in combination with anti-cancer therapies.

Official Title

A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Subjects With Solid Malignancies

Quick Facts

Study Start:2021-09-15

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05006794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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 zamzetoclax (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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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 zamzetoclax (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.

Contacts and Locations

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, 80045

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

START Midwest

Grand Rapids, Michigan, 49546

United States

Montefiore Medial Center - Montefiore Medical Park

Bronx, New York, 10467

United States

Novant Health Cancer Institute - Elizabeth (Breast Cancer)

Charlotte, North Carolina, 28204

United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

United States

Oregon Health Oregon Health & Sciences University-Knight Cancer Institute

Portland, Oregon, 97239

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

START San Antonio

San Antonio, Texas, 78229

United States

START Mountain Region

West Valley City, Utah, 84119

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15

Study Completion Date2029-03

Study Record Updates

Study Start Date2021-09-15

Study Completion Date2029-03

Terms related to this study

Additional Relevant MeSH Terms

Solid Malignancies