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NCT06167317

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

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 17 versions: 10 with changes below, 7 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 74 words
    • Trial sites expanded: 8 → 14 locations
  2. Study sites: 7 to 8v16
  3. Eligibility criteria shortened, about 29 words
    • Enrollment target: 254 to 278
    v15
  4. Site details revised at 1 of 7 sitesv14
  5. Eligibility criteria revised
    • Enrollment target: 248 to 254
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 3 to 7v5
  2. Study sites: 2 to 3v4
  3. Start date changed from estimate of Jan 2024 to Jan 9, 2024v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date: Dec 2023 to Jan 2024
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation
Timeframe: 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)
Timeframe: First dose up to 30 days post last dose (Up to approximately 109 weeks).
The Incidence of Laboratory Abnormalities
Timeframe: First dose up to 30 days post last dose (Up to approximately 109 weeks).

Secondary (8)

Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201
PK Parameter: Cmax of GS-0201
PK Parameter: Tmax of GS-0201
PK Parameter: AUC0-168 of SG (Parts C and D only)
PK Parameter: Cmax of SG (Parts C and D only)
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PK Parameter: Tmax of SG (Parts C and D only)
GS-0201 Plasma Concentrations
Sacituzumab Govitecan (SG) Serum Concentrations (Parts C and D only)

Arms and interventions

Part A: GS-0201 Monotherapy Dose EscalationExperimental

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.

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

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

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

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

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.

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

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.

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

Participants with recurrent/persistent endometrial cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.

Drugs: GS-0201, Sacituzumab Govitecan

Sites

14 sites in 3 countries

South Korea 5, United States 5, Israel 4