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

Description

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.

Conditions

Lymphoma, B-Cell, Lymphoma, T-Cell

Study Overview

Study Details

Study overview

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.

An Open-Label, First in Human, Phase 1/2 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

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

Condition
Lymphoma, B-Cell
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Step Pharma, SAS,

Maureen Higgins, STUDY_DIRECTOR, Step Pharma

Study Record Dates

2025-12