NCT05463263 A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
| NCT ID | NCT05463263 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Step Pharma, SAS |
| Condition | Lymphoma, B-Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-08-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 180 participants in total. It began in 2022-08-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Maureen Higgins
STUDY DIRECTOR
Step Pharma
Frequently Asked Questions
Who can join the NCT05463263 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, B-Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05463263 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05463263 currently recruiting?
Yes, NCT05463263 is actively recruiting participants. Contact the research team at STP938-101@step-ph.com for enrollment information.
Where is the NCT05463263 trial being conducted?
This trial is being conducted at Denver, United States, Sarasota, United States, New York, United States, Paris, France and 11 additional locations.
Who is sponsoring the NCT05463263 clinical trial?
NCT05463263 is sponsored by Step Pharma, SAS. The principal investigator is Maureen Higgins at Step Pharma. The trial plans to enroll 180 participants.