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Phase 1/2 Study of STP938 for Relapsed/Refractory Lymphoma

This study is testing a new drug called STP938 for adults with B-cell or T-cell lymphoma that has come back or not responded to previous treatments. STP938 works by blocking an enzyme (a protein that speeds up chemical reactions) called CTPS1, which cancer cells need to grow. The first part of the study will find the safest dose of STP938. The second part will see how well STP938 treats different types of lymphoma. You may be able to join if you are 18 or older, have B-cell or T-cell lymphoma, and have already received at least two other treatments. The study is currently unclear on its recruitment status.

Study design
This is an interventional Phase 1/2 study planning to enroll 180 participants. It will test STP938 as a single treatment.
What's involved
You would take STP938 as a tablet. Blood samples will be taken throughout the study to monitor the drug's effects.
Compensation
Not stated in the trial record.
Follow-up
Safety and how well the treatment works will be measured through study completion, which is an average of 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05463263

A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

Recruiting
PHASE1Ages 18+InterventionalTreatment
Step Pharma, SAS
~180 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:STP938

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability (Phase 1 / Dose Escalation)
Measured over Through study completion, an average of 9 months
+1 more outcome measured

Conditions

Lymphoma, B-Cell
Lymphoma, T-Cell

Explore related trials

B-Cell Non-Hodgkin LymphomaT-Cell Non-Hodgkin Lymphoma

NCT05463263

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Imperial College / Clinical Trials Unit, Hammersmith Hospital

    London, United Kingdomstudy coordinator listed

    Recruiting

  • Institut Paoli Calmettes

    Marseille, Francestudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering

    New York, New Yorkstudy coordinator listed

    Recruiting

  • The Royal Marsden

    Sutton, United Kingdomstudy coordinator listed

    Recruiting

  • CHU de Nantes

    Nantes, Franceno site contact published

    Recruiting

  • Churchill Hospital

    Oxford, United Kingdomno site contact published

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Coloradono site contact published

    Recruiting

  • Derriford Hospital

    Plymouth, United Kingdomno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Maureen Higgins · STUDY_DIRECTOR · Step Pharma

Who to contact

Maureen Higgins
[email protected]
+33 1 86 26 43 56
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Safety and Tolerability (Phase 1 / Dose Escalation)Through study completion, an average of 9 months

    Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)

  • Objective Response Rate (ORR) (Phase 2 / Dose Expansion)Through study completion, an average of 9 months

    ORR is defined as the proportion of subjects achieving a confirmed response (complete response \[CR\] or partial response \[PR\]). Evaluation of ORR will be via standard response criteria