Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06372717
PHASE1

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

Sponsor: Apollo Therapeutics Ltd

View on ClinicalTrials.gov

Summary

This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).

Official title: A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome/AML (MDS/AML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-06-04

Completion Date

2027-05-01

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

APL-4098

APL-4098 is administered orally in 28-day cycles

DRUG

Azacitidine and APL-4098

Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; APL-4098 is administered orally.

DRUG

Azacitidine and Venetoclax and APL-4098

Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; Venetoclax is administered orally; APL-4098 is administered orally.

Locations (7)

Monash Health

Clayton, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

The Royal Marsden Hospital

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom