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Lymphoma, B-CellPhase 1/2NCT05463263

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

A Phase 1/2 study testing STP938 in people with Lymphoma, B-Cell and Lymphoma, T-Cell, run by Step Pharma, SAS at 15 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell, Lymphoma, T-Cell
What is being tested?
STP938
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
15 sitesin 3 countries
Study dates
3 Aug 2022to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Maureen Higgins contact

+33 1 86 26 43 56

STP938-101@step-ph.com

Duc Tran contact

+33 1 86 26 43 56

STP938-101@step-ph.com

15 sites in 3 countries

United Kingdom7 sites, 7 recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester

    Matthew Ahearne

    Recruiting

  • Imperial College / Clinical Trials Unit, Hammersmith Hospital

    London

    Lucy Cook, 0203 313 4340

    Recruiting

  • The Christie

    Manchester

    Kim Linton

    Recruiting

  • Nottingham City Hospital

    Nottingham

    Chris Fox

    Recruiting

  • Churchill Hospital

    Oxford

    Graham Collins

    Recruiting

  • Derriford Hospital

    Plymouth

    David Lewis

    Recruiting

  • The Royal Marsden

    Sutton

    Dima El Sharkawi, HaemOncGT@rmh.nhs.uk

    Recruiting

Other trials in United Kingdom

France5 sites, 5 recruiting

  • The Centre Léon Bérard

    Lyon

    Yann Guillerman

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Jean Laurent L'Attention, : +33 (0)4 9122 37 29

    Robin Noel

    Recruiting

  • CHU de Nantes

    Nantes

    Benoit Tessoulin

    Recruiting

  • Hôpital Saint-Louis

    Paris, Paris, 75610

    Halim Bataouche

    Adèle de Masson

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Vincent Ribrag

    Recruiting

Other trials in France

United States3 sites, 3 recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    M Tees

    Recruiting

  • Memorial Sloan Kettering

    New York, New York, 10065

    Robert Stuver, 646-608-4308

    Robert Stuver

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    M Patel

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
STP938
Medical subject headings
Lymphoma, B-Cell, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STP938Drug

    Small molecule

Study groups in NCT05463263
Study groupRoleWhat they receive
Phase 1 (Part 1, Dose Escalation)ExperimentalUp to 5 dose levels with STP938 administered as oral monotherapy
Receives: Drug: STP938
Phase 2 (Part 2; expansion)ExperimentalAt defined dose level(s) with STP938 administered as oral monotherapy
Receives: Drug: STP938

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability (Phase 1 / Dose Escalation)

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

    Measured: Through study completion, an average of 9 months

  2. Objective Response Rate (ORR) (Phase 2 / Dose Expansion)

    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

    Measured: Through study completion, an average of 9 months

Secondary outcomes (10)

  1. Maximum plasma concentration (Cmax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

    Pharmacokinetic parameter from plasma STP938 levels

    Measured: 16 Days

  2. Time to reach maximum concentration (TMax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

    Pharmacokinetic parameter from plasma STP938 levels

    Measured: 16 Days

  3. Area under the curve (AUC) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

    Pharmacokinetic parameter from plasma STP938 levels

    Measured: 16 Days

  4. Evaluate preliminary clinical activity of STP938 (Phase 1)

    Evaluation of ORR using standard response criteria

    Measured: Through study completion, an average of 9 months

  5. Evaluate best overall response of STP938 (Phase 1 / Phase 2)

    Evaluation of best overall response (Complete response [CR], Partial response [PR], Stable disease [SD], Progression of disease [PD], Not evaluable, Not applicable) using standard response criteria

    Measured: Through study completion, an average of 9 months

  6. Evaluation Time To Respond (Phase 1 / Phase 2)

    Time to response (TTR) defined as the time from first dose of STP938 to the date of first CR or PR response assessment

    Measured: Through study completion, an average of 9 months

  7. Evaluation Duration of Response (Phase 1 / Phase 2)

    Duration of response (DoR) is defined as the time, in days, from the date measurement criteria that are first met for CR or PR (whichever is first recorded) to the first date that relapse, progressive disease or death, whichever occurs first

    Measured: Through study completion, an average of 9 months

  8. Evaluation Progression Free Survival (Phase 1 / Phase 2)

    Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first

    Measured: Through study completion, an average of 9 months

  9. Evaluation of Complete Response Rate (Phase 2)

    Complete Response Rate using standard response criteria

    Measured: Through study completion, an average of 9 months

  10. Safety and Tolerability (Phase 2 / Dose Expansion)

    Incidence of SAEs and TEAEs

    Measured: Through study completion, an average of 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start3 Aug 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Patients will be assigned to a dose level of STP938 (Phase 1) or an expansion cohort (Phase 2) at the time of their enrollment.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463263
Sponsor's protocol ID
STP938-101
Status last verified
Jun 2026
First submitted
30 Jun 2022
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Asnagli H, Minet N, Pfeiffer C, Hoeben E, Lane R, Laughton D, Birch L, Jones G, Novak A, Parker AE, Ludwig H, Fischer A, Latour S, Beer PA. CTP Synthase 1 Is a Novel Therapeutic Target in Lymphoma. Hemasphere. 2023 Mar 28;7(4):e864. doi: 10.1097/HS9.0000000000000864. eCollection 2023 Apr.

    PubMed 37008165

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing STP938 in people with Lymphoma, B-Cell and Lymphoma, T-Cell, run by Step Pharma, SAS at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United Kingdom, France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maureen Higgins (+33 1 86 26 43 56, STP938-101@step-ph.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (Phase 1 / Dose Escalation) (time frame: Through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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