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
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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

First listed
Jul 18, 2022
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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