Clinical trial · Interventional
Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Non-Hodgkin Lymphoma (NHL) | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Chronic Lymphocytic Leukaemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S 55746 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B-cell Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)
- interventionNames
- Drug: S 55746
- type
- EXPERIMENTAL
- label
- Chronic Lymphocytic Leukaemia (CLL)
- interventionNames
- Drug: S 55746
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- During cycle 1 (21 days)
- description
- The MTD is the highest drug dosage that is unlikely (\<25% posterior probability) to cause DLT in more than 33% of the treated patients in the first cycle of S 55746 treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women or men aged \>/=18 years * Patients with a measurable histologically confirmed Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Small Lymphocytic Lymphoma (SLL) and Marginal Zone Lymphoma (MZL) (Arm A), or patients with an evaluable immunophenotypically confirmed CLL (Arm B), or patients with a measurable Multiple Myeloma t(11;14) (arm A expansion part) according to International Myeloma Working Group (IMWG) criteria * Relapsed after or refractory disease to standard treatments, and require treatment in the opinion of the investigator * Estimated life expectancy \> 12 weeks * World Health Organization (WHO) performance status 0-2 * Adequate bone marrow, renal and hepatic functions * No evidence or treatment for another malignancy within 2 years prior to study entry. Curatively treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia is allowed Additional inclusion criteria for food interaction cohort: * B-cell NHL patients at low risk of tumour lysis syndrome (TLS) * Recent/concomitant treatment altering gastric pH Exclusion Criteria: * Previous treatment with a BH3 mimetic * Previous therapy for the studied disease within 3 weeks before first intake * Radioimmunotherapy, radiotherapy within 8 weeks before first intake * Major surgery within 3 weeks before first day of study drug dosing * Corticosteroids \>= 20 mg prednisone equivalent per day within 7 days before first intake * Anticoagulant oral drugs, aspirin \> 325 mg/day within 7 days prior to first S 55746 intake * Positive direct antiglobulin test (Coombs test) and haptoglobin below normal value * Prior allogenic stem cell transplant * Autologous stem cell transplant within 3 months before first intake * NHL patients diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukaemia * Human immunodeficiency virus (HIV) * Known acute or chronic hepatitis B or hepatitis C * Impaired cardiac function * Medications known to prolong corrected QT (QTc) interval * History or/ clinically suspicious for cancer- related Central Nervous System disease * Solitary extramedullary plasmacytoma * Laboratory Signs of TLS * Strong or moderate CYP3A4 inhibitors/inducers (treatment, food or drink products) * Treatment highly metabolized by the CYP3A4 or CYP2D6 and/or substrates with a narrow therapeutic index, multienzyme and/or OATP and/or P-gp substrates or herbal products. * Known hypersensitivity to rasburicase * Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolytic anaemia * Patients receiving proton pump inhibitor
References
Publications (1)
- BACKGROUNDLe Gouill S, Wermke M, Morschhauser F, Lim ST, Salles G, Kloos I, de Burgat V, Becquart M, Paux G, Kraus-Berthier L, Pennaforte S, Stilgenbauer S, Walewski J, Ribrag V. A new BCL-2 Inhibitor (S55746/BCL201) as Monotherapy in Patients with Relapsed or Refractory Non-hodgkin Lymphoma: Preliminary Results of the First-in-human Study. Hematol Oncol. 2017 Jun 07;35(S5):14-17. doi: 10.1002/hon.2437_30