Overview

Dose Escalation/ Expansion Trial of CA-4948 as Monotherapy and in Combination With Azacitidine or Venetoclax in Patients With AML or MDS

Status:
Recruiting

Trial end date:
2022-02-01

Target enrollment:

Participant gender:

Summary

This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered CA-4948 monotherapy and in combination with azacitidine or venetoclax in adult patients with Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS). - R/R AML, FLT3-ITD mutant AML patients after failing at least 1 to 3 pretreatments, including a FLT3 inhibitor - R/R AML with FLT3 WT, after failing 1 to 3 pretreatments. Desired enrichment for expression of spliceosome mutations - R/R hrMDS with spliceosome mutations (SF3B1, U2AF1, SRSF2, ZRSR2), resistant/refractory to HMA; ineligible for intensive chemotherapy; maximal 3 pretreatments - R/R hrMDS without spliceosome mutations; resistant/refractory to r/r to HMA; ineligible for intensive chemotherapy; maximal 3 pretreatments

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Curis, Inc.

Treatments:

Azacitidine
Venetoclax