STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Trial sites expanded: 10 → 14 locations
    • Interventions modified
    • Eligibility criteria expanded, about 14 words
  2. Study sites: 9 to 10v9
  3. Trial sites expanded: 6 → 9 locationsv8
  4. Trial sites expanded: 3 → 6 locations
    • Site contacts updated at 1 of 6 sites
    v7
  5. Study sites: 3 to 6v6
  6. Primary completion pushed from Dec 29, 2026 to Dec 29, 2027v5 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 188 → 107 participants
    • Study completion pushed from Jun 29, 2027 to Jun 29, 2028
    • Trial arms changed: 5 → 3
    • Interventions: STC-15 in combination with toripalimab (Combination Product) to STC-15 in combination with toripalimab (Combination Product), STC-15 monotherapy (Drug)
    • Eligibility criteria shortened, about 169 words
    • Secondary endpoints revised (5)
    • Study title expanded, about 8 words
  7. Primary completion date: Oct 29, 2025 to Dec 29, 2026
    • Study completion date: Jan 29, 2026 to Jun 29, 2027
    v4
  8. Study sites: 2 to 3v3
  9. Study sites: 1 to 2v2
  10. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in advanced unresectable or metastatic tumors. The Phase 2 Monotherapy part is an open-label, non-randomized, multicenter Simon's 2-stage design that investigates the safety, tolerability, and antitumor activity of STC-15 in participants with selected, relapsed sarcomas subtypes, dedifferentiated (DD) liposarcoma and leiomyosarcoma (uterine and non-uterine).
Trial Details
NCT Number NCT06975293
Lead Sponsor STORM Therapeutics LTD
Collaborators: Coherus Oncology, Inc.
Conditions
(from sponsor)		 Solid Tumor, Sarcoma, Leiomyosarcoma, Dedifferentiated Liposarcoma
Related terms Leiomyosarcoma, Liposarcoma, Sarcoma
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov