Testing STP938 for patients with relapsed or refractory B-Cell and T-Cell lymphomas

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 study evaluates the safety and effectiveness of STP938, an inhibitor of the enzyme CTPS1, in treating adult patients with relapsed or refractory B-cell and T-cell lymphomas. The trial consists of two phases: the first phase focuses on dose escalation to determine the maximum tolerated dose, while the second phase expands to assess the drug's efficacy across five different lymphoma types. Participants will receive STP938 as a tablet, and blood samples will be collected to monitor the drug's effects on both the lymphoma and the body. The study aims to provide insights into a new treatment option for patients with limited alternatives.

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.
* Relapsed/refractory patients with histologically confirmed diagnosis of B cell or T cell lymphoma
* Must have received at least 2 prior systemic therapies and have no treatment options known to provide clinical benefit
* Must have measurable disease per Lugano lymphoma classification except for cutaneous T-cell lymphoma (CTCL) which is measured via International Society for Cutaneous Lymphomas (ISCL)/ European Organization of Research and Treatment of Cancer (EORTC).
* 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 child bearing potential or males unwilling to comply with contraception requirements.
* Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.
* Active malignancy within 2 years of study enrollment
* Prior radiation or surgical resection of their lymphoma without additional sites of measurable disease outside of the radiation field or subjects who have received prior radiation or surgical resection of their lymphoma ≤2 weeks prior to the first dose of study drug.
* 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 who have received a live vaccine within 30 days prior to study enrollment or whilst participating in the study.
* 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).
* Subjects who received a severe acute respiratory syndrome coronavirus 2 vaccine ≤3 weeks prior to study drug dosing.

Where it's running

• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Memorial Sloan Kettering
  New York, New York, United States Recruiting
• Hôpital Saint-Louis
  Paris, Paris, France Recruiting
• The Centre Léon Bérard
  Lyon, France Recruiting
• Institut Paoli Calmettes
  Marseille, France Recruiting

Study contacts

• Study coordinator: Maureen Higgins
• Email: STP938-101@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.