A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

Part of paid clinical trials in Denver, Colorado.

Sponsor
Step Pharma, SAS
Study ID
NCT05463263
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lymphoma, B-Cell
  • Lymphoma, T-Cell

Eligibility Criteria

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

Interventions

  • STP938 — DRUG
    Small molecule

Study Details

The Phase 1 part of the study is a dose escalation of STP938 as monotherapy. The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas.

Key Dates

Start date
Aug 3, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Phase 1 (Part 1, Dose Escalation)
    Up to 5 dose levels with STP938 administered as oral monotherapy
  • Experimental: Phase 2 (Part 2; expansion)
    At defined dose level(s) with STP938 administered as oral monotherapy

Primary Outcome Measure

Safety and Tolerability (Phase 1 / Dose Escalation) [ Time Frame: Through study completion, an average of 9 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218
M Tees
Florida Cancer SpecialistsSarasotaFlorida34232
M Patel
Memorial Sloan KetteringNew YorkNew York10065
Robert Stuver
646-608-4308
Robert Stuver (PRINCIPAL_INVESTIGATOR)

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By research site
Colorado Blood Cancer Institute· Denver, COFlorida Cancer Specialists· Sarasota, FLMemorial Sloan Kettering· New York, NY

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