Testing STP938 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Maureen Higgins
• Email: STP938-201@step-ph.com
• Phone: +33 1 86 26 43 56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.