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

Launched by STEP PHARMA, SAS · Jul 14, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called STP938 for adults with certain types of lymphoma, which is a cancer that affects the lymphatic system. The study has two parts: the first part will find the best dose of STP938 to use, while the second part will look at how well it works in patients with five different forms of B-cell and T-cell lymphomas. The trial is currently recruiting participants who are 18 years or older, have had at least two previous treatments for their lymphoma that didn't work, and have measurable cancer that can be assessed.

To be eligible for the trial, participants need to be able to sign consent, have a confirmed diagnosis of B-cell or T-cell lymphoma, and have certain health criteria, such as good organ function and a life expectancy of more than three months. People who are pregnant, have certain active infections, or have had recent treatments that could interfere with the study may not be able to participate. Those who join the trial can expect to receive STP938 and will be closely monitored for its effects and any side effects. Overall, this study aims to provide more options for patients who have not responded to other treatments.

Gender

ALL

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.