AstraZene- AZD3632 Mono or in Comb with Anticancer Agents in subjects with w/ KMT2Ar, NPM1m, w/ HOX

Purpose of this Study

This study has three parts: - Screening (up to 21 days): You'll get health checks like heart tests, scans, and blood work. - Study Drug Period (28-day cycles): You'll be randomly placed in one of two groups: - One group gets AZD3632 alone. -The other gets AZD3632 with another medicine called posaconazole. You'll have regular visits for tests and questions. - After Treatment: You'll have a safety check 30 days after your last dose, then visits every 12 weeks to see how your disease is doing.

Who Can Participate?

Eligibility

Adults with certain blood cancers; like AML, ALL, MPAL, AUL, or MDS—can join this study. Some parts of the study are for people whose cancer has come back, which means there are more than 5% cancer cells in their bone marrow again.

Age Range

18-100

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

This study is being done to see if a new medicine called AZD3632 is safe and works well for people with certain blood cancers called acute leukemia or MDS.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants with Advanced Haematologic Malignancies with KMT2Ar, NPM1m, or Other Genotypes Associated with HOX Overexpression

Principal Investigator

Harry
Erba

Protocol Number

PRO00118800

NCT ID

NCT07155226

Phase

I/II

Enrollment Status

Pending Open to Enrollment