Recruiting
Phase 1
Phase 2

STP938

Sponsor:

Step Pharma, SAS

Code:

NCT05463263

Conditions

Lymphoma, B-Cell

Lymphoma, T-Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STP938

Study Details

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.

Conditions

Lymphoma, B-Cell

Lymphoma, T-Cell

Study ID

NCT05463263

Start date

Aug 3, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 (Part 1, Dose Escalation)

Up to 5 dose levels with STP938 administered as oral monotherapy

experimental: Phase 2 (Part 2; expansion)

At defined dose level(s) with STP938 administered as oral monotherapy

Interventions

STP938

Small molecule

Primary outcome measure

  • Safety and Tolerability (Phase 1 / Dose Escalation) [ Time Frame: Through study completion, an average of 9 months ]
  • Objective Response Rate (ORR) (Phase 2 / Dose Expansion) [ Time Frame: Through study completion, an average of 9 months ]

Central Contacts and Locations

Central contacts

Maureen Higgins

+33 1 86 26 43 56STP938-101@step-ph.com

Duc Tran

+33 1 86 26 43 56STP938-101@step-ph.com

Locations

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Memorial Sloan Kettering

Recruiting

New York, New York, United States, 10065

Contacts

Robert Stuver

646-608-4308

Principal Investigator:

Robert Stuver

More Information

Sponsor

Step Pharma, SAS

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Step Pharma, SAS on 2026-06-16.