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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Gilead Sciences
Study ID
NCT06167317
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GS-0201 — DRUG
    Pill administered orally
  • Sacituzumab Govitecan — DRUG
    Administered intravenously

Study Details

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

Key Dates

Start date
Jan 9, 2024
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
278 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: GS-0201 Monotherapy Dose Escalation
    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.
  • Experimental: Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion
    Participants with selected breast cancer indication will receive GS-0201 monotherapy at the recommended dose for expansion.
  • Experimental: Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion
    Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion.
  • Experimental: Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG)
    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.
  • Experimental: Part D: Cohort D1: Dose Expansion: GS-0201 + SG
    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.
  • Experimental: Part D: Cohort D2: Dose Expansion: GS-0201 + SG
    Participants with recurrent/persistent endometrial cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.

Primary Outcome Measure

The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation [ Time Frame: First dose up to 30 days post last dose (Up to approximately 109 weeks). ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02459-
NEXT AustinAustinTexas78758-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
NEXT DallasIrvingTexas75039-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MANEXT Austin· Austin, TXThe University of Texas MD Anderson Cancer Center· Houston, TXNEXT Dallas· Irving, TX

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