NCT06445907

Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the safety and tolerability of the drug combination of Q702, azacitidine, and venetoclax when given to participants with relapsed/refractory AML.

Detailed description

Primary Objective: \- To evaluate safety of Q702 and the combination of azacitidine, venetoclax. Secondary Objectives: * To estimate rate of CR/CRh/CRi by 4 treatment cycles * To estimate overall response rate (ORR) * To estimate rate of MRD negative by 4 treatment cycles * To estimate overall survival (OS) * To estimate relapse-free survival (RFS) Exploratory Objectives: * To determine the plasma concentration and pharmacokinetic (PK) parameters of Q702 when dosed in combination with azole antifungals in AML patients * To estimate duration of response (DOR) * To estimate median time to blood count recovery * To estimate median time to first response * To estimate median time to negative MRD * To study drug-drug interactions with CYP3A4 inhibitor azole antifungals * Additional response and survival endpoints * To explore biomarkers of response, pathway engagement, and resistance

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given by IV
DRUG	Venetoclax	Given by PO
DRUG	Q702	Given by PO

Timeline

• Start date: 2025-02-12
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2024-06-06
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study