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Looking for participantsPhase1/Phase2

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

Sponsor: Step Pharma, SAS

NCT ID: NCT05463263

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
STP938 (drug)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
STP938 — drug: Small molecule
Patient visit burden
Not specified by the sponsor

In plain English

This early-stage (Phase 1/2) study is testing a new medicine called STP938 (also known as Dencatistat) in adults whose B-cell or T-cell lymphoma has come back or has not responded to treatment. It is run by Step Pharma, SAS.

Who can take part

  • Adults aged 18 or over
  • Lymphoma that has come back or not responded to treatment, confirmed by tissue testing
  • Have had at least 2 previous whole-body (systemic) treatments with no other options known to help
  • Have lymphoma that can be measured on scans or tests (with a special skin-based measure for a type that affects the skin)
  • Fairly well day-to-day (performance status score of 2 or less on a scale used by doctors)
  • Expected to live more than 3 months, in the doctor's view
  • Good working bone marrow, liver, kidneys and blood clotting
  • Side effects from earlier cancer treatment must have mostly cleared up (except hair loss), and written agreement (consent) to take part

Who may not be able to

  • Women who are pregnant or breastfeeding, and people not willing to follow contraception rules
  • Lymphoma in the brain or spinal cord fluid
  • Another cancer within the last 2 years
  • Radiotherapy or surgery for lymphoma less than 2 weeks before the first dose, or with no other measurable disease outside the treated area
  • Cancer treatment, antibody therapy or experimental drugs within 4 weeks before joining (or less than 5 half-lives, if shorter)
  • Serious uncontrolled other illness
  • Weakened immune system or an opportunistic infection in the last 12 months
  • Active or long-term hepatitis B, or active hepatitis C
  • A live vaccine within 30 days before joining or during the study
  • A heart tracing (electrocardiogram, or ECG) showing a corrected QT interval over 470 milliseconds
  • A COVID-19 vaccine within 3 weeks before the first dose

What taking part involves

  • • Taking the study medicine STP938 (Dencatistat) — exact doses and schedule are not stated; ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
180
Started
2022-08-03
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for lymphoma, b-cell
  • • Phase1/Phase2 - 180 participants
  • • The Phase 1 part of the study is a dose escalation of STP938 as monotherapy

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lymphoma, b-cell

Where?

  • • Leicester - University Hospitals of Leicester NHS Trust
  • • London - Imperial College / Clinical Trials Unit, Hammersmith Hospital
  • • Manchester - The Christie
  • • Nottingham - Nottingham City Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The Phase 1 part of the study is a dose escalation of STP938 as monotherapy. The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas.

More detail

The drug STP938 is an inhibitor of an enzyme called cytidine triphosphate synthase 1 (CTPS1). CTPS1, and a very similar enzyme cytidine triphosphate synthase 2 (CTPS2), control the final step in the production of the cytidine triphosphate (CTP). CTP is an essential building block of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). Studies of people with inherited mutations of the CTPS1 gene indicate that certain types of blood cells required CTPS1 in order to divide rapidly, whereas other cells in the body use the CTPS2 enzyme. Based on these observations, it is expected that blocking CTPS1, using the drug STP938, may be an effective treatment for certain types of cancer that arise from blood cells. The purpose of this study is to see if STP938 is effective at treating different types of lymphoma. STP938 will be given as a tablet. Blood samples will be taken during the study in order to understand the effects of STP938 on the lymphoma and on the rest of the body. The main outcome of the first part of the study is to see if STP938 can be given safely to patients with lymphoma, and to work out the best dose of STP938. The main outcome of the second part of the study is to see if ST938 is effective in treating different types of lymphoma.

Lymphoma, B-CellLymphoma, T-Cell

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ authorization
  • ✓ resolved to ≤Grade 1 or returned to baseline levels

What the study is looking for

  • ✓Signed and dated agreement to take part, and able to comply with the study procedures and any locally required authorization.
  • ✓Male or female aged ≥ 18 years.
  • ✓Relapsed/refractory patients with confirmed by a biopsy 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
  • ✓activity scale (ECOG) performance status ≤2.

Who cannot take part

  • ✗Pregnant or breastfeeding females and women of child bearing potential or males unwilling to comply with...
  • ✗Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.
  • ✗Active cancer within 2 years of study enrollment
  • ✗Uncontrolled intercurrent illness.
  • ✗Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in...
See the full 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 Is This Study? (7 UK sites)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Imperial College / Clinical Trials Unit, Hammersmith Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Lucy Cook0203 313 4340

The Christie

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Nottingham City Hospital

Nottingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Churchill Hospital

Oxford, United Kingdom

Recruiting

Derriford Hospital

Plymouth, United Kingdom

Recruiting

The Royal Marsden

Sutton, United Kingdom

Recruiting
Site contact (verified)
Dima El SharkawiHaemOncGT@rmh.nhs.uk

How to Get in Touch

Maureen Higgins

Sponsor contact

CONTACT

+33 1 86 26 43 56 STP938-101@step-ph.com

Duc Tran

Sponsor contact

CONTACT

+33 1 86 26 43 56 STP938-101@step-ph.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06