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A Phase 1 Study to Investigate SNDX-6352 Alone or in Combination With Durvalumab in Patients With Solid Tumors

Solid Tumor Clinical Trial

Official title:
A Phase 1, Open-Label, Dose Escalation Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of SNDX-6352 Monotherapy and SNDX-6352 in Combination With Durvalumab in Patients With Unresectable, Recurrent, Locally-Advanced, or Metastatic Solid Tumors

Clinical Trial Summary

A Phase 1 dose escalation study to determine if SNDX-6352 as monotherapy and SNDX-6352 in combination with a fixed dose of durvalumab will be sufficiently safe and well-tolerated at biologically active doses to warrant further investigation in patients with solid tumors.

Clinical Trial 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 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03238027
Study type Interventional
Source Syndax Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date September 1, 2017
Completion date November 20, 2020
View Details
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