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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Small molecule
Colorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
Safety and Tolerability (Phase 1 / Dose Escalation)
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
Time frame: 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
Time frame: Through study completion, an average of 9 months
Maximum plasma concentration (Cmax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)
Pharmacokinetic parameter from plasma STP938 levels
Time frame: 16 Days
Time to reach maximum concentration (TMax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)
Pharmacokinetic parameter from plasma STP938 levels
Time frame: 16 Days
Area under the curve (AUC) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)
Pharmacokinetic parameter from plasma STP938 levels
Time frame: 16 Days
Evaluate preliminary clinical activity of STP938 (Phase 1)
Evaluation of ORR using standard response criteria
Time frame: Through study completion, an average of 9 months
Evaluate best overall response of STP938 (Phase 1 / Phase 2)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Memorial Sloan Kettering
New York, New York, United States
RECRUITINGThe Centre Léon Bérard
Lyon, France
RECRUITINGInstitut Paoli Calmettes
Marseille, France
RECRUITINGCHU de Nantes
Nantes, France
RECRUITINGHôpital Saint-Louis
Paris, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGUniversity Hospitals of Leicester NHS Trust
Leicester, United Kingdom
RECRUITINGImperial College / Clinical Trials Unit, Hammersmith Hospital
London, United Kingdom
RECRUITING...and 5 more locations
Time frame: Through study completion, an average of 9 months
Evaluation Time To Respond (Phase 1 / Phase 2)
Time to response (TTR) defined as the time from first dose of STP938 to the date of first CR or PR response assessment
Time frame: Through study completion, an average of 9 months
Evaluation Duration of Response (Phase 1 / Phase 2)
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
Time frame: Through study completion, an average of 9 months
Evaluation Progression Free Survival (Phase 1 / Phase 2)
Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first
Time frame: Through study completion, an average of 9 months
Evaluation of Complete Response Rate (Phase 2)
Complete Response Rate using standard response criteria
Time frame: Through study completion, an average of 9 months
Safety and Tolerability (Phase 2 / Dose Expansion)
Incidence of SAEs and TEAEs
Time frame: Through study completion, an average of 9 months