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

NCT05463263 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STP938-101
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 15

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

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability (Phase 1 / Dose Escalation)

  Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)

  Through study completion, an average of 9 months

• Objective Response Rate (ORR) (Phase 2 / Dose Expansion)

  ORR is defined as the proportion of subjects achieving a confirmed response (complete response \[CR\] or partial response \[PR\]). Evaluation of ORR will be via standard response criteria

  Through study completion, an average of 9 months

Secondary Outcomes (10)

• Maximum plasma concentration (Cmax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

  16 Days

• Time to reach maximum concentration (TMax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

  16 Days

• Area under the curve (AUC) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

  16 Days

• Evaluate preliminary clinical activity of STP938 (Phase 1)

  Through study completion, an average of 9 months

• Evaluate best overall response of STP938 (Phase 1 / Phase 2)

  Through study completion, an average of 9 months

Study Arms (2)

Phase 1 (Part 1, Dose Escalation)

EXPERIMENTAL

Up to 5 dose levels with STP938 administered as oral monotherapy

Drug: STP938

Phase 2 (Part 2; expansion)

EXPERIMENTAL

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

Drug: STP938

Interventions

STP938 DRUG

Small molecule

Phase 1 (Part 1, Dose Escalation); Phase 2 (Part 2; expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Step Pharma, SAS: lead

Study Sites (15)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Memorial Sloan Kettering

New York, New York, 10065, United States

RECRUITING

Hôpital Saint-Louis

Paris, Paris, 75610, France

RECRUITING

The Centre Léon Bérard

Lyon, France

RECRUITING

Institut Paoli Calmettes

Marseille, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Imperial College / Clinical Trials Unit, Hammersmith Hospital

London, United Kingdom

RECRUITING

The Christie

Manchester, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, United Kingdom

RECRUITING

Churchill Hospital

Oxford, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, United Kingdom

RECRUITING

The Royal Marsden

Sutton, United Kingdom

RECRUITING

Related Publications (1)

• Asnagli H, Minet N, Pfeiffer C, Hoeben E, Lane R, Laughton D, Birch L, Jones G, Novak A, Parker AE, Ludwig H, Fischer A, Latour S, Beer PA. CTP Synthase 1 Is a Novel Therapeutic Target in Lymphoma. Hemasphere. 2023 Mar 28;7(4):e864. doi: 10.1097/HS9.0000000000000864. eCollection 2023 Apr.

  PMID: 37008165 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maureen Higgins

  Step Pharma

  STUDY DIRECTOR

Central Study Contacts

Maureen Higgins

CONTACT

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

Duc Tran

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to a dose level of STP938 (Phase 1) or an expansion cohort (Phase 2) at the time of their enrollment.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 18, 2022
• Study Start: August 3, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); FR (5); US (3)