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Status:

RECRUITING

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

Lead Sponsor:

Gilead Sciences

Conditions:

Advanced Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced sol...

Eligibility Criteria

Inclusion

  • Able to understand and give written informed consent.
  • Assigned female or male at birth, 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.
  • Organ function requirements:
  • Adequate hematologic function
  • Adequate hepatic function
  • Creatinine clearance
  • Coagulation
  • Tissue requirement:
  • Parts A, B, C, and D:
  • Pre-treatment tumor tissue is required.
  • Parts A and C backfill biopsy cohorts:
  • Participants must agree to fresh pre- and on-treatment biopsies.
  • Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
  • Willing and able to comply with the requirements and restrictions in this protocol
  • Part A (GS-0201 Monotherapy Dose Escalation)
  • Histologically/cytologically confirmed progressive/advanced solid tumors with selected molecular lesions.
  • Participants must have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy
  • Part B (Dose Expansion)
  • Disease documented as:
  • Cohort B1:
  • Histologically or cytologically confirmed progressive/advanced selected solid tumor diagnoses harboring defined molecular lesions
  • Participants may potentially be required to forgo treatment with approved agent(s) to be able to participate in the study
  • Cohort B2:
  • Histologically or cytologically confirmed progressive/advanced solid tumor diagnoses harboring defined molecular lesions not included in Cohort B1
  • Participants must have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy
  • Part C (Dose Escalation)
  • Histologically or cytologically confirmed unresectable locally advanced/metastatic selected solid tumors
  • Part D (Dose Expansion)
  • Disease documented as:
  • Cohort D1:
  • Histologically or cytologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
  • Cohort D2:
  • Histologically or cytologically confirmed unresectable locally advanced or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ in situ hybridization (ISH-)) breast cancer.

Exclusion

  • Pregnant or lactating females
  • Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients
  • Requirement for ongoing therapy with or use of any prohibited medications described in the protocol
  • Participants with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of GS-0201
  • The therapies listed below within the specified timeframe:
  • Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) \< 4 weeks prior to planned Cycle 1 Day 1
  • Immunotherapy or biologic therapy \< 21 days prior to planned Cycle 1 Day 1
  • Chemotherapy \< 14 days prior to planned Cycle 1 Day 1, or \< 42 days for mitomycin or nitrosoureas
  • Targeted small molecule therapy \< 14 days prior to planned Cycle 1 Day 1
  • Receipt of experimental therapy within 21 days or 5 experimental treatment half-lives (whichever is longer) prior to planned Cycle 1 Day 1
  • Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started \< 14 days prior to planned Cycle 1 Day 1 are not permitted. Hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started ≥ 14 days prior to planned Cycle 1 Day 1
  • Radiotherapy within 2 weeks prior to planned Cycle 1 Day 1 and the radiation is not administered to a target lesion
  • Any prior allogeneic tissue/solid organ transplantation, including allogeneic hematopoietic stem cell transplantation. Participants with a history of autologous hematopoietic stem cell transplantation are also excluded
  • Have not recovered (ie, Grade 1 or lower) from AEs due to a previously administered agent
  • Prior treatment with approved or experimental prohibited agents as detailed in the protocol.
  • Diagnosis of immunodeficiency, either primary or acquired, or requires systemic corticosteroids (\> 10 mg of prednisone daily, or equivalent). However, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
  • Have an active second malignancy
  • Have known active central nervous system (CNS) metastases
  • Participants with carcinomatous meningitis or primary CNS tumors are excluded regardless of clinical stability
  • Meet any of the following criteria for cardiac disease:
  • Myocardial infarction or unstable angina pectoris within 6 months of enrollment
  • History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)
  • QT interval \> 470 msec
  • New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction less than 40%
  • Meet any of the following infectious criteria:
  • Have active serious infection requiring antimicrobials
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV. In participants with a history of HBV or HCV, participants with detectable viral loads will be excluded
  • Participants who test positive for hepatitis B surface antigen. Participants who test positive for hepatitis B core antibody are eligible with a negative HBV DNA by quantitative Polymerase chain reaction (PCR)
  • Participants who test positive for HCV antibody. Participants who test positive for HCV antibody are eligible with a negative HCV RNA by quantitative PCR
  • Participants who test positive for HIV antibody
  • History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or radiation pneumonitis requiring steroids
  • Symptomatic ascites or pleural effusion
  • Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
  • Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the study
  • Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of study drug(s) (inactivated, viral vector vaccines, and messenger RNA (mRNA) vaccines are allowed; seasonal vaccines should be up to date prior to planned Cycle 1 Day 1)
  • Parts C (Dose Escalation) and D (Dose Expansion): Combination Cohorts:
  • Participants with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and participants with a history of bowel obstruction or gastrointestinal perforation within 6 months prior to planned Cycle 1 Day 1
  • Participants who previously received topoisomerase 1 inhibitors or antibody-drug conjugates containing a topoisomerase 1 inhibitor
  • Known severe intolerance or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous (IV) immunoglobulin preparations; any history of anaphylaxis; history of human anti-human antibody response

Key Trial Info

Start Date :

January 9 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2028

Estimated Enrollment :

254 Patients enrolled

Trial Details

Trial ID

NCT06167317

Start Date

January 9 2024

End Date

September 1 2028

Last Update

March 12 2025

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02459

2

NEXT Austin

Austin, Texas, United States, 78758

3

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

4

NEXT Dallas

Irving, Texas, United States, 75039