Ph 1/2 Study of CTPS1 Inhibitor STP938 in Subjects with Relapsed/Refractory B-cell/T cell Lymphoma
Research type
Research Study
Full title
An Open-Label, First in Human, Phase 1/2 Study 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
IRAS ID
1005146
Contact name
Maureen Higgins
Contact email
Sponsor organisation
Step Pharma, SAS.
Eudract number
2022-000848-30
Clinicaltrials.gov Identifier
Research summary
The aim of the study to find a safe and tolerable dose of a new experimental treatment, STP938, and to learn whether this treatment will be an effective treatment option for patients with lymphoma who have failed to respond to treatment, have no available approved therapy (or who have refused available, approved therapy) or whose disease has recurred following available standard therapies. STP938 is the first in a novel class of drugs that specifically targets cancer cells. In preclinical animal studies, this drug showed anticancer activity and was found to be safe. This study is an open-Label, first in human, phase 1/2 study that comprise of two parts. Part 1 is a dose escalation phase that will involve a smaller cohort of participants and Part 2 will involve a dose expansion phase. The approximate duration of the study treatment will be 6-9 months (16-19 visits) with an estimated 12-month follow-up period involving 3-monthly visits. Participants will receive STP938 capsules twice daily in 28-day treatment cycles as long as they are tolerating the treatment and it is deemed beneficial. The response to the treatment will be assessed by radiographic tumour assessment, using either a CT Scan, MRI or PET Scan. A Safety Monitoring Committee will review all data related to the risk or benefit of the investigational medication, on an ongoing basis. Any dose increase will be carefully reviewed and decided upon by SRC. The following study procedures will be performed: (a) physical examinations (b) ECGs (c) blood tests, (d) urine tests (e) CT/MRI/PET scans (f) tumour biopsies (g) bone marrow aspirations.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0163
Date of REC Opinion
15 Jul 2022
REC opinion
Further Information Favourable Opinion