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Clinical Trials in the USA / NCT06297525
Recruiting Phase 1

Study of STP938 (Dencatistat) in Advanced Solid Tumours

NCT06297525 · tracked via the Priya Life Science USA tracker
Sponsor
Step Pharma, SAS
Phase
Phase 1
Started
2024-08-02
Last updated
2026-06-16

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

STP938

STP938: Small molecule

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Main Inclusion Criteria: * Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * Male or female aged ≥ 18 years. * Advanced disease not curable by available therapies and requires systemic therapy. * Histologically confirmed diagnosis of eligible cancer type. * Must have tumor tissue available for biomarker testing. * Measurable disease (Part 1) and measurable disease per RECIST (Part2) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Life expectancy \> 3 months as assessed by the Investigator. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). * All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment. Main Exclusion Criteria: * Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements. * Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression * Active malignancy within 2 years of study enrollment * Prior radiation within 2 weeks of start of therapy. * Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \<5 half-lives since completion of previous investigational therapy, whichever is shorter. * Uncontrolled intercurrent illness. * Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months. * Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. * Subjects with corrected QT interval \>470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Comprehensive Hematology Oncology, LLC St. Petersburg Florida Recruiting
Mary Crowley Cancer Research Center Dallas Texas Recruiting
Next Oncology San Antonio Texas Recruiting
Institut Gustave Roussy Villejuif Paris Recruiting
The Beatson Institute for Cancer Research Glasgow Glasgow Recruiting
University College London London United Kingdom Recruiting
The Christie Manchester United Kingdom Recruiting

More Step Pharma, SAS trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06297525 on ClinicalTrials.gov ↗ ← All trials in the USA