Status:
RECRUITING
A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
Lead Sponsor:
Step Pharma, SAS
Conditions:
Lymphoma, B-Cell
Lymphoma, T-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
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 p...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05463263
Start Date
August 3 2022
End Date
December 1 2025
Last Update
April 15 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
3
Memorial Sloan Kettering
New York, New York, United States, 10065
4
The Centre Léon Bérard
Lyon, France