Study of STP938 in Advanced Solid Tumours
- Registration Number
- NCT06297525
- Lead Sponsor
- Step Pharma, SAS
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a (Part 1, Dose Escalation) STP938 Up to 5 dose levels with STP938 administered as oral monotherapy Phase 1b (Part 2, Safety Expansion) STP938 Further evaluation of STP938 administered as oral monotherapy at the RP2D
- Primary Outcome Measures
Name Time Method Safety and Tolerability Through study completion, an average of 6 months Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Time to reach maximum concentration (TMax) 9 Days Pharmacokinetic parameter from plasma STP938 levels
Evaluation of preliminary clinical activity of STP938 Through study completion, an average of 6 months Evaluation of ORR using standard response criteria
Maximum plasma concentration (Cmax) 9 Days Pharmacokinetic parameter from plasma STP938 levels
Evaluation of Duration of Response Through study completion, an average of 6 months Duration of response (DoR) is defined as the time, in days, from the date measurement criteria that are first met for CR or PR (whichever is first recorded) to the first date that relapse, progressive disease or death, whichever occurs first
Evaluation of Progression Free Survival Through study completion, an average of 6 months Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first
Area under the curve (AUC) of STP938 9 days Pharmacokinetic parameter from plasma STP938 levels
Evaluation of best overall response of STP938 Through study completion, an average of 6 months Evaluation of best overall response (Complete response \[CR\], Partial response \[PR\], Stable disease \[SD\], Progression of disease \[PD\], Not evaluable, Not applicable) using standard response criteria
Change in serum CA125 (ovarian cancer only) Through study completion, an average of 6 months Evaluation of CA125 using standard response criteria
Trial Locations
- Locations (7)
Institut Gustave Roussy
🇫🇷Villejuif, Paris, France
University College London
🇬🇧London, United Kingdom
Comprehensive Hematology Oncology, LLC
🇺🇸Saint Petersburg, Florida, United States
The Beatson Institute for Cancer Research
🇬🇧Glasgow, United Kingdom
Mary Crowley Cancer Research Center
🇺🇸Dallas, Texas, United States
Next Oncology
🇺🇸San Antonio, Texas, United States
The Christie
🇬🇧Manchester, United Kingdom