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Recruiting Phase 1 NCT06297525

Study of STP938 in Advanced Solid Tumours

Phase 1 – testing safety in a small group of people
Conditions: Solid Tumor

Sponsor: Step Pharma, SAS

trial.available_in: БГ
Overview
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.
Who can participate
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
STP938
DRUG
Locations 7
France (1)
Institut Gustave Roussy
Villejuif , Paris
United Kingdom (3)
The Beatson Institute for Cancer Research
Glasgow , Glasgow
University College London
London
The Christie
Manchester
United States (3)
Mary Crowley Cancer Research Center
Dallas , Texas
Next Oncology
San Antonio , Texas
Comprehensive Hematology Oncology, LLC
St. Petersburg , Florida
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.08.2024
Completion date
01.05.2027
Registry ID
NCT06297525
Source
clinicaltrials.gov
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