Testing STP938 for advanced solid tumors
An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects With Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer
This study is testing a new drug called STP938 to see if it can safely help people with advanced solid tumors who have few other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Step Pharma, SAS Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (St. Petersburg, Florida and 6 other locations) |
| Trial ID | NCT06297525 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of STP938 in patients with advanced solid tumors. It consists of a Phase 1a dose escalation to determine the optimal dosage and a Phase 1b safety expansion cohort to further assess the drug's safety profile. Participants will receive STP938 as a monotherapy, and their tumor tissue will be analyzed for biomarker testing. The study aims to provide insights into the potential therapeutic benefits of STP938 for patients with limited treatment options.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that require systemic therapy and have measurable disease.
Not a fit: Patients who are pregnant, breastfeeding, or have tumors that are curable by existing therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that are not curable by existing therapies.
How similar studies have performed: While this approach is part of ongoing research, similar studies have shown promise in targeting advanced solid tumors with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
St. Petersburg, Florida and 6 other locations
- Comprehensive Hematology Oncology, LLC — St. Petersburg, Florida, United States (Recruiting)
- Mary Crowley Cancer Research Center — Dallas, Texas, United States (Recruiting)
- Next Oncology — San Antonio, Texas, United States (Recruiting)
- Institut Gustave Roussy — Villejuif, Paris, France (Recruiting)
- The Beatson Institute for Cancer Research — Glasgow, Glasgow, United Kingdom (Recruiting)
- University College London — London, United Kingdom (Recruiting)
- The Christie — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Maureen Higgins
- Email: STP938-201@step-ph.com
- Phone: +33 1 86 26 43 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.