CTP Synthase 1 Is a Novel Therapeutic Target in Lymphoma.
Hélène Asnagli, Norbert Minet, Christina Pfeiffer...
https://pubmed.ncbi.nlm.nih.gov/37008165Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05463263
An Open-Label Phase 1/2 Study Evaluating Safety, Tolerability, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 in Adults With Relapsed/Refractory B-Cell and T-Cell Lymphomas
Led by Step Pharma, SAS · Updated on 2026-04-23
180
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug STP938, an inhibitor of the enzyme CTPS1, which plays a key role in the production of essential building blocks for DNA and RNA. This study focuses on adults with relapsed or refractory B-cell and T-cell lymphomas, aiming to evaluate the safety, dosing, and potential effectiveness of STP938 in treating these blood cancers. The trial includes both a Phase 1 dose escalation and a Phase 2 cohort expansion to explore different lymphoma types. STP938 is given orally as a tablet, first in increasing doses during Phase 1 to determine the best dose and safety. Phase 2 involves expanding treatment at defined dose levels to assess its activity across five types of B and T cell lymphomas. Participants receive STP938 as monotherapy throughout these phases without combination with other treatments. Participants will undergo regular blood tests to monitor the effects of STP938 on lymphoma and overall health. Researchers will measure safety, response rates, and how well the drug is tolerated over an average of nine months. Pharmacokinetics, including how the drug is absorbed and processed in the body, will also be studied. Follow-up will include assessments to understand treatment response duration and progression-free survival.
CONDITIONS
Brief Title
A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Male or female aged 18 years or older
- Diagnosed with relapsed or refractory B-cell or T-cell lymphoma confirmed by tissue analysis
- Received at least two prior systemic therapies without effective treatment options
- Measurable disease per standard lymphoma criteria (Lugano classification or ISCL/EORTC for cutaneous T-cell lymphoma)
- ECOG performance status of 2 or less
- Life expectancy greater than 3 months
- Adequate bone marrow, liver, kidney function, and blood clotting
- Any side effects from prior cancer treatments, except hair loss, must be resolved to mild or baseline levels before enrollment
You will not qualify if you...
- Pregnant or breastfeeding females, or individuals unwilling to use contraception
- Known involvement of lymphoma in the central nervous system or carcinomatous meningitis
- Active cancer within 2 years before enrollment
- Recent radiation or surgery for lymphoma within 2 weeks before starting study drug without other measurable disease
- Use of systemic cancer treatments, monoclonal antibodies, other investigational drugs within 4 weeks before enrollment or less than 5 half-lives since last investigational treatment
- Uncontrolled illnesses
- Immunocompromised with recent opportunistic infections within 12 months
- Active or chronic hepatitis B or active hepatitis C infection
- Receipt of live vaccine within 30 days before or during the study
- Corrected QT interval over 470 msec on electrocardiogram
- COVID-19 vaccine received within 3 weeks prior to study drug dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 9 months through study completion
Participants receive the study drug STP938 as oral monotherapy to evaluate safety, tolerability, and preliminary efficacy for treating lymphoma.
Regular visits for dosing and monitoring during treatment
Trial Site Locations
Total: 15 locations
1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Memorial Sloan Kettering
New York, New York, United States, 10065
Actively Recruiting
4
Hôpital Saint-Louis
Paris, Paris, France, 75610
Actively Recruiting
5
The Centre Léon Bérard
Lyon, France
Actively Recruiting
6
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
7
CHU de Nantes
Nantes, France
Actively Recruiting
8
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
9
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Actively Recruiting
10
Imperial College / Clinical Trials Unit, Hammersmith Hospital
London, United Kingdom
Actively Recruiting
11
The Christie
Manchester, United Kingdom
Actively Recruiting
12
Nottingham City Hospital
Nottingham, United Kingdom
Actively Recruiting
13
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
14
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
15
The Royal Marsden
Sutton, United Kingdom
Actively Recruiting
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Research Team
M
Maureen Higgins
D
Duc Tran
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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