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

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.

Conditions

Solid Malignancies

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Malignancies
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States, 80045

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

Bronx

Montefiore Medial Center - Montefiore Medical Park, Bronx, New York, United States, 10467

Charlotte

Novant Health Cancer Institute - Elizabeth (Breast Cancer), Charlotte, North Carolina, United States, 28204

Oklahoma City

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Portland

Oregon Health Oregon Health & Sciences University-Knight Cancer Institute, Portland, Oregon, United States, 97239

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

San Antonio

START San Antonio, San Antonio, Texas, United States, 78229

West Valley City

START Mountain Region, West Valley City, Utah, United States, 84119

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2027-01