Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Step Pharma, SAS (Voir sur ClinicalTrials)
août 2022
décembre 2025
16 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 31/05/2024 09:16:37 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Nantes - Nantes - France | Benoit Tessoulin | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - 75610 - Paris - France | Halim Bataouche | Contact (sur clinicalTrials) | |||
| Institut Gustave Roussy - Villejuif - France | Vincent Ribrag | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Jean Laurent L'Attention | Contact (sur clinicalTrials) | |||
| The Centre Léon Bérard - Lyon - France | Yann Guillerman | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.