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

An Open-Label, First in Human, Phase 1/2 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

This study is testing a new drug called STP938 to see if it can help adults with tough-to-treat B-cell and T-cell lymphomas feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Step Pharma, SAS (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 15 sites (Denver, Colorado and 14 other locations)
• Trial ID: NCT05463263 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory B-cell or T-cell lymphomas who have received at least two prior systemic therapies.

Not a fit: Patients with lymphoma types that do not meet the inclusion criteria or those who have not exhausted other treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat lymphomas.

How similar studies have performed: While this approach is novel in targeting CTPS1 for lymphoma treatment, similar studies targeting other enzymes have shown promise in cancer therapies.

Eligibility 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.
* 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 this trial is running

Denver, Colorado and 14 other locations

• 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)
• CHU de Nantes — Nantes, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Recruiting)
• University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
• Imperial College / Clinical Trials Unit, Hammersmith Hospital — London, United Kingdom (Recruiting)
• The Christie — Manchester, United Kingdom (Recruiting)
• Nottingham City Hospital — Nottingham, United Kingdom (Recruiting)
• Churchill Hospital — Oxford, United Kingdom (Recruiting)
• Derriford Hospital — Plymouth, United Kingdom (Recruiting)
• The Royal Marsden — Sutton, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Maureen Higgins

Conditions Lymphoma, B-Cell; Lymphoma, T-Cell