RecruitingPhase 1Phase 2NCT05463263

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


Sponsor

Step Pharma, SAS

Enrollment

180 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria11

  • 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.

Interventions

DRUGSTP938

Small molecule


Locations(15)

Colorado Blood Cancer Institute

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Memorial Sloan Kettering

New York, New York, United States

The Centre Léon Bérard

Lyon, France

Institut Paoli Calmettes

Marseille, France

CHU de Nantes

Nantes, France

Hôpital Saint-Louis

Paris, France

Institut Gustave Roussy

Villejuif, France

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Imperial College / Clinical Trials Unit, Hammersmith Hospital

London, United Kingdom

The Christie

Manchester, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

The Royal Marsden

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05463263


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