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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05463263
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Step Pharma, SAS

Tracking Information
First Submitted Date  ICMJE June 30, 2022
First Posted Date  ICMJE July 18, 2022
Last Update Posted Date September 21, 2023
Actual Study Start Date  ICMJE August 3, 2022
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2022)
  • Safety and Tolerability (Phase 1 / Dose Escalation) [ Time Frame: Through study completion, an average of 9 months ]
    Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
  • Objective Response Rate (ORR) (Phase 2 / Dose Expansion) [ Time Frame: Through study completion, an average of 9 months ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2022)
  • Maximum plasma concentration (Cmax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation) [ Time Frame: 16 Days ]
    Pharmacokinetic parameter from plasma STP938 levels
  • Time to reach maximum concentration (TMax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation) [ Time Frame: 16 Days ]
    Pharmacokinetic parameter from plasma STP938 levels
  • Area under the curve (AUC) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation) [ Time Frame: 16 Days ]
    Pharmacokinetic parameter from plasma STP938 levels
  • Evaluate preliminary clinical activity of STP938 (Phase 1) [ Time Frame: Through study completion, an average of 9 months ]
    Evaluation of ORR using standard response criteria
  • Evaluate best overall response of STP938 (Phase 1 / Phase 2) [ Time Frame: Through study completion, an average of 9 months ]
    Evaluation of best overall response (Complete response [CR], Partial response [PR], Stable disease [SD], Progression of disease [PD], Not evaluable, Not applicable) using standard response criteria
  • Evaluation Time To Respond (Phase 1 / Phase 2) [ Time Frame: Through study completion, an average of 9 months ]
    Time to response (TTR) defined as the time from first dose of STP938 to the date of first CR or PR response assessment
  • Evaluation Duration of Response (Phase 1 / Phase 2) [ Time Frame: Through study completion, an average of 9 months ]
    Duration of response (DoR) is defined as the time, in days, from the date measurement criteria that are first met for CR or PR (whichever is first recorded) to the first date that relapse, progressive disease or death, whichever occurs first
  • Evaluation Progression Free Survival (Phase 1 / Phase 2) [ Time Frame: Through study completion, an average of 9 months ]
    Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first
  • Evaluation of Complete Response Rate (Phase 2) [ Time Frame: Through study completion, an average of 9 months ]
    Complete Response Rate using standard response criteria
  • Safety and Tolerability (Phase 2 / Dose Expansion) [ Time Frame: Through study completion, an average of 9 months ]
    Incidence of SAEs and TEAEs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
Official Title  ICMJE 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
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.

Detailed Description

The drug STP938 is an inhibitor of an enzyme called cytidine triphosphate synthase 1 (CTPS1). CTPS1, and a very similar enzyme cytidine triphosphate synthase 2 (CTPS2), control the final step in the production of the cytidine triphosphate (CTP). CTP is an essential building block of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). Studies of people with inherited mutations of the CTPS1 gene indicate that certain types of blood cells required CTPS1 in order to divide rapidly, whereas other cells in the body use the CTPS2 enzyme. Based on these observations, it is expected that blocking CTPS1, using the drug STP938, may be an effective treatment for certain types of cancer that arise from blood cells.

The purpose of this study is to see if STP938 is effective at treating different types of lymphoma. STP938 will be given as a tablet. Blood samples will be taken during the study in order to understand the effects of STP938 on the lymphoma and on the rest of the body. The main outcome of the first part of the study is to see if STP938 can be given safely to patients with lymphoma, and to work out the best dose of STP938. The main outcome of the second part of the study is to see if ST938 is effective in treating different types of lymphoma.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Patients will be assigned to a dose level of STP938 (Phase 1) or an expansion cohort (Phase 2) at the time of their enrollment.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell
Intervention  ICMJE Drug: STP938
Small molecule
Study Arms  ICMJE
  • Experimental: Phase 1 (Part 1, Dose Escalation)
    Up to 5 dose levels with STP938 administered as oral monotherapy
    Intervention: Drug: STP938
  • Experimental: Phase 2 (Part 2; expansion)
    At defined dose level(s) with STP938 administered as oral monotherapy
    Intervention: Drug: STP938
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2022)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maureen Higgins +33 1 86 26 43 56 STP938-101@step-ph.com
Contact: Duc Tran +33 1 86 26 43 56 STP938-101@step-ph.com
Listed Location Countries  ICMJE France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05463263
Other Study ID Numbers  ICMJE STP938-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Step Pharma, SAS
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Step Pharma, SAS
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maureen Higgins Step Pharma
PRS Account Step Pharma, SAS
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP