Study of STP938 (Dencatistat) in Advanced Solid Tumours

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Step Pharma, SAS
Study ID
NCT06297525
Phase
PHASE1
Status
Recruiting

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • STP938 — DRUG
    Small molecule

Study Details

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

Key Dates

First listed
Mar 7, 2024
Start date
Aug 2, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: Phase 1a (Part 1, Dose Escalation)
    Up to 5 dose levels with STP938 administered as oral monotherapy
  • Experimental: Phase 1b (Part 2, Safety Expansion)
    Further evaluation of STP938 administered as oral monotherapy at the RP2D

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Comprehensive Hematology Oncology, LLCSt. PetersburgFlorida33709-
Mary Crowley Cancer Research CenterDallasTexas75251-
Next OncologySan AntonioTexas78292-

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