Approval Probability
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Adjusted LOA
ML Risk
SP-3164 · 1 trial · 1 indication
Dose Escalation (Part 1) • To characterize the safety, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of SP-3164
Dose Escalation (Part 1) • To characterize the safety, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of SP-3164
Dose Escalation (Part 1) • To characterize the safety, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of SP-3164
Dose Selection Optimization (Part 2) • To further characterize the safety of the two selected doses of SP-3164 from part 1 and determine the recommended phase 2 dose (RP2D) of SP-3164 for future studies
• To further characterize the safety of the two selected doses of SP-3164 from part 1 and determine the recommended phase 2 dose (RP2D) of SP-3164 for future studies
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | For part 1 dose escalation, one patient per dose cohort will be initially recruited (accelerated titration dose-escalation, single-patient cohorts/dose level) for the first two dose levels or until the first instance of a ≥ Grade 2 toxicity (excluding Grade 2 neutropenia and lymphopenia and adverse events unequivocally due to the underlying disease or to an extraneous cause), or dose-limiting toxicity (DLT), whichever occurs earlier. Further cohorts will be recruited in blocks of three patients, i.e., 3+3 dose escalation design. |
| Dose Optimization | EXPERIMENTAL | For part 2 dose selection optimization, two dose levels will be selected by the Safety Review Committee (SRC) based on review of all available data on safety, tolerability, PK, PD, and preliminary efficacy from part 1. The dose selection optimization will include only patients with R/R DLBCL and will randomize 1:1 approximately 30 new patients at the two selected dose levels (15 patients to each of the two selected dose levels) before declaring the RP2D. Assessment of PK/PD of SP-3164 will be included in part 2 dose selection optimization. |
| Name | Type | Description |
|---|---|---|
| SP-3164 | DRUG | SP-3164, an oral next generation cereblon-binding molecular glue 'protein degrader' |
Inclusion Criteria: Diagnosis (WHO 2016 criteria) of R/R B-cell NHL in dose escalation (part 1) and limited to R/R DLBCL in dose selection optimization (part 2) confirmed by biopsy and immunophenotyping Dose escalation: at time of enrollment, R/R B-cell NHL patients per WHO 2016 criteria including...
SP-3164 is an investigational small molecule being studied for the treatment of relapsed or refractory Non-Hodgkin's Lymphoma in adults. It is currently in early Phase 1 clinical development and has not been approved by regulatory authorities.
SP-3164 is being developed by Salarius Pharmaceuticals, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with Non-Hodgkin's Lymphoma.
SP-3164 is in Phase 1 clinical development. The ongoing study is an early Phase 1 trial that is not yet recruiting participants. The drug is investigational and has not received regulatory approval for any use.
SP-3164 is being studied in a single clinical trial with the identifier NCT05979857. This trial is titled 'Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma' and is designed to enroll 72 adult participants.
SP-3164 is not FDA approved. It is an investigational drug currently in early Phase 1 clinical trials for Non-Hodgkin's Lymphoma. The drug has not completed clinical development and its safety and efficacy have not been established.