CTP Synthase 1 Is a Novel Therapeutic Target in Lymphoma.
Hélène Asnagli, Norbert Minet, Christina Pfeiffer...
https://pubmed.ncbi.nlm.nih.gov/37008165/Actively Recruiting
Led by Step Pharma, SAS · Updated on 2026-06-16
180
Participants Needed
15
Research Sites
N/A
Total Duration
Researchers are evaluating the drug STP938, an inhibitor of the enzyme CTPS1, in adults with relapsed or refractory B-cell and T-cell lymphomas. This study aims to determine the safety, tolerability, best dose, and preliminary effectiveness of STP938 in treating these lymphomas. The study includes two parts a Phase 1 dose escalation and a Phase 2 cohort expansion. STP938 is given orally as a tablet. In Phase 1, participants receive increasing doses of STP938 to find the best dose that can be safely administered. In Phase 2, the drug is given at the determined dose to different groups of patients with various types of B and T cell lymphomas. Blood samples are collected throughout the study to assess the drugs effects on lymphoma and the body. Participants will be monitored for safety, drug absorption, and treatment response for about nine months. Assessments include measuring drug levels in the blood and evaluating tumor response and progression using established lymphoma criteria. The study tracks how well participants tolerate the treatment and how their disease responds, with ongoing safety checks during the study period.
CONDITIONS
A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
M
Maureen Higgins
D
Duc Tran
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Step Pharma, SAS
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | STP938 trial regimen | Current-care regimens (per guidelines) |
|---|---|---|
| What is it? | A new investigational oral drug (STP938) that selectively inhibits CTP synthase 1, being tested for safety and antitumor activity in adults with B-cell and T-cell lymphomas who have not responded to or have relapsed after at least two prior therapies. | Salvage chemotherapy regimens (such as DHAP or ICE) and, where appropriate, targeted therapies (e.g., brentuximab vedotin for CD30+ disease or other approved targeted agents), as recommended by guidelines for heavily pretreated relapsed/refractory lymphoma. |
| Role in study or in patient care | Investigational study drug evaluated in a multi-part, sequential dose-escalation and expansion protocol for relapsed or refractory lymphoma at an advanced treatment line. | Clinical guideline-recommended options for patients who have experienced relapse or are refractory after multiple prior lines, tailored according to prior therapies, lymphoma subtype, and patient-specific factors. |
| Primary use / clinical intent | Evaluated for safety, tolerability, and preliminary antitumor activity as a new potential therapy for patients with limited remaining treatment options. | To achieve disease control or remission in relapsed or refractory lymphoma and optimize symptom management as per best available evidence in later-line or multiply pretreated settings. |
| How is it given or performed? | Oral administration of STP938 in a protocol-defined dose, with participants enrolled in sequential cohorts to determine safe and active doses. | Regimen-specific; salvage chemotherapy agents are typically administered intravenously in cycles (e.g., every 21–28 days), while targeted agents may be oral or intravenous depending on the drug. Regimens and dosing are selected according to patient history and current guideline criteria. |
| Evidence status / supporting data | Safety and antitumor activity are under early-phase investigation; no peer-reviewed published clinical outcome data in patients yet reported. | Established clinical benefit and toxicity profiles supported by phase II/III trials and long clinical experience, though outcomes are variable by regimen, disease subtype, and prior therapies. |
| Important limitations | Safety, optimal dose, clinical activity, and long-term effects remain unknown; open-label, non-randomized design limits comparison with established regimens. Only eligible for patients in advanced-line settings with prior heavy treatment. | Current regimens may have limited efficacy in heavily pretreated patients, substantial side effects, or be unsuitable due to comorbidities; options and outcomes are often dictated by prior treatments, disease subtype, and patient health. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several months depending on individual dosing schedules
Participants receive increasing oral doses of STP938 to determine the safest and most effective dose.
Regular visits for safety and blood monitoring
Duration - Approximately 9 months
Participants receive STP938 at the determined dose to evaluate its effects on different lymphoma types.
Regular visits for treatment and evaluation
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Hélène Asnagli, Norbert Minet, Christina Pfeiffer...
https://pubmed.ncbi.nlm.nih.gov/37008165/Step Pharma, SAS
Lead Sponsor