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

NCT06167317 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GS-US-686-6854
• Study Type: interventional
• Target: 254
• Locations: 2 countries
• Sites: 7

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 solid tumors. The primary objectives of this study are to:

• To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors
• To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation

  DLTs are defined as any of the following treatment-emergent adverse events (AEs) regardless of attribution (graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), unless clearly related to an underlying disease or extraneous causes, with onset within the DLT-evaluation period for the corresponding dose.

  First dose up to 30 days post last dose (Up to approximately 109 weeks).

• The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  First dose up to 30 days post last dose (Up to approximately 109 weeks).

• The Incidence of Laboratory Abnormalities

  First dose up to 30 days post last dose (Up to approximately 109 weeks).

Secondary Outcomes (8)

• Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201

  Predose and postdose up to end of treatment (up to 105 weeks)

• PK Parameter: Cmax of GS-0201

  Predose and postdose up to end of treatment (up to 105 weeks)

• PK Parameter: Tmax of GS-0201

  Predose and postdose up to end of treatment (up to 105 weeks)

• PK Parameter: AUC0-168 of SG (Parts C and D only)

  Predose and postdose up to end of treatment (up to 105 weeks)

• PK Parameter: Cmax of SG (Parts C and D only)

  Predose and postdose up to end of treatment (up to 105 weeks)

Study Arms (6)

Part A: GS-0201 Monotherapy Dose Escalation

EXPERIMENTAL

Participants will receive escalating doses of GS-0201 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first.

Drug: GS-0201

Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion

EXPERIMENTAL

Participants with selected indications will receive GS-0201 monotherapy at the recommended dose for expansion.

Drug: GS-0201

Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion

EXPERIMENTAL

Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion.

Drug: GS-0201

Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG)

EXPERIMENTAL

Participants will receive escalating doses of GS-0201 in combination with SG, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first.

Drug: GS-0201; Drug: Sacituzumab Govitecan

Part D: Cohort D1: Dose Expansion: GS-0201 + SG

EXPERIMENTAL

Participants with confirmed unresectable locally advanced or metastatic triple negative breast cancer (mTNBC) will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.

Drug: GS-0201; Drug: Sacituzumab Govitecan

Part D: Cohort D2: Dose Expansion: GS-0201 + SG

EXPERIMENTAL

Participants with confirmed unresectable locally advanced or metastatic HR+/HER2- breast cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.

Drug: GS-0201; Drug: Sacituzumab Govitecan

Interventions

GS-0201 DRUG

Pill administered orally

Part A: GS-0201 Monotherapy Dose Escalation; Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion; Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion; Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG); Part D: Cohort D1: Dose Expansion: GS-0201 + SG; Part D: Cohort D2: Dose Expansion: GS-0201 + SG

Sacituzumab Govitecan DRUG

Administered intravenously

Also known as: IMMU-132, Trodelvy™, GS-0132

Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG); Part D: Cohort D1: Dose Expansion: GS-0201 + SG; Part D: Cohort D2: Dose Expansion: GS-0201 + SG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (7)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02459, United States

RECRUITING

NEXT Austin

Austin, Texas, 78758, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

sacituzumab govitecan

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: January 9, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); US (4)