A Phase 1 Study to Investigate SNDX-6352 Alone or in Combination With Durvalumab in Patients With Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Locally Advanced Malignant Neoplasm
- Metastatic Tumor
- Solid Tumor
- Unresectable Malignant Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Initially in both phases, 3 patients will receive SNDX-6352 at 1 mg/kg IV on C1D1 and again on C1D15 of a 28-day cycle. Phase 1b only will also receive a fixed dose of 1500mg durvalumab IV on C1D1. If no DLTs are noted, 3 more patients will be treated at the next higher dose level (3 mg/kg). If 1 DLT is observed in 1 of 3 patients, 3 more patients will be treated at that starting dose level (1 mg/kg). If 2 or more DLTs are observed in 3-6 patients at the starting dose, the study will be terminated or a lower dose will be considered. If the safety profile is acceptable, escalation to SNDX-6352 doses of 3, 6 and 10mg/kg are planned for the 1a and for the 1b, doses of 3 and 6 mg/kg of SNDX-6352 in combination with a fixed dose of 1500mg of durvalumab are planned. The MTD will be considered to have been exceeded if 2 or more patients in a dose group experience a DLT; in this case, the next lower dose group which has been evaluated will be considered as the MTD.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open label, multi-center Phase 1 study consisting of Phase 1a and Phase 1b. The study will evaluate SNDX-6352 monotherapy (in Phase 1a) and SNDX-6352 combined with durvalumab (in Phase 1b) in patients with advanced solid tumors which must have progressed following prior treatment and have...
This is an open label, multi-center Phase 1 study consisting of Phase 1a and Phase 1b. The study will evaluate SNDX-6352 monotherapy (in Phase 1a) and SNDX-6352 combined with durvalumab (in Phase 1b) in patients with advanced solid tumors which must have progressed following prior treatment and have no standard therapy alternatives left (i.e.. patients must not be candidates for regimens known to provide clinical benefit). The primary objective will be to determine the MTD and/or RP2D of SNDX-6352 as monotherapy (Phase 1a) and in combination with durvalumab (Phase 1b) as evaluated by the incidence of AEs that are defined as DLTs. In both study phases, a standard "3+3"dose escalation schema will be used to determine an MTD with 3-6 evaluable patients enrolled per dose level. The RP2D will be determined based on data from the dose escalation patients as reviewed by the Safety Review Committee (SRC; comprised of investigators and the Sponsor).
Tracking Information
- NCT #
- NCT03238027
- Collaborators
- Not Provided
- Investigators
- Study Director: Michael Meyers, MD Syndax Pharmaceuticals, Inc.
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