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NCT07601243

Study of GS-2426 in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 4 → 8 locations
  2. Eligibility criteria expanded, about 13 words
    • Primary endpoints: details revised at 1 of 5 entries
    • Study sites: 4 to 6
  3. Study sites: 2 to 4v3
  4. Recruitment openedv2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2026 to Jun 2, 2026
    • Primary endpoints revised (5)
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)
Timeframe: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timeframe: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)
Timeframe: First dose up to 21 days post first dose
Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
Timeframe: First dose up to 21 days post first dose
Recommended Phase 2 Dose (RP2D)
Timeframe: Predose to end of study (up to 105 weeks)

Secondary (4)

Plasma Concentration of GS-2426
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426
PK Parameters: Cmax of GS-2426
PK Parameters: Tmax of GS-2426

Arms and interventions

Phase 1a: Monotherapy Dose EscalationExperimental

Participants will receive escalating doses of GS-2426 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 week, whichever occurs first.

Phase 1b: Monotherapy Dose ExpansionExperimental

Participants will be enrolled in different indication-specific cohorts. Participants will receive GS-2426 monotherapy at the recommended dose until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 weeks, whichever occurs first.

Drugs: GS-2426

Sites

8 sites in 2 countries

United States 5, Spain 3