Approval Probability
TA Base Rate
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 adult non-Hodgkin's lymphoma, specifically in patients with relapsed or refractory disease. It is in early clinical development and has not been approved for any indication.
SP-3164 is being developed by Decoy Therapeutics Inc., which trades under the ticker DCOY. The company is the sponsor of the clinical program evaluating the drug in adult non-Hodgkin's lymphoma.
SP-3164 is in Phase 1 clinical development. Its only registered trial is listed as an early Phase 1 study, and the drug remains investigational, meaning it has not received FDA approval for any use.
SP-3164 is being evaluated in a single registered trial, NCT05979857, titled Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma. The trial is an early Phase 1 study with a planned enrollment of 72 participants and is currently not yet recruiting.
The NCT05979857 trial of SP-3164 enrolls adults aged 18 years and older of any sex who have relapsed or refractory non-Hodgkin's lymphoma. Healthy volunteers are not eligible, and the study is controlled but not randomized or double blinded.