NCT06297525PHASE1Recruiting
Study of STP938 (Dencatistat) in Advanced Solid Tumours
Step Pharma, SAS
Start Date
8/2/2024
Completion Date
5/1/2027
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 Criteria
Age Range: 18 years to No maximum
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).
Interventions
DRUG
STP938
Conditions
Solid Tumor
Locations
Comprehensive Hematology Oncology, LLC
St. Petersburg, Florida 33709
United States
Mary Crowley Cancer Research Center
Dallas, Texas 75251
United States
Next Oncology
San Antonio, Texas 78292
United States
Institut Gustave Roussy
Villejuif, Paris 94805
France
The Beatson Institute for Cancer Research
Glasgow, Glasgow G12 8QQ
United Kingdom
University College London
London,
United Kingdom
The Christie
Manchester, M20 4BX
United Kingdom