A study to investigate APL-4098 in adults with advanced AML or MDS
Research type
Research Study
Full title
A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and/or in Combination with Azacitidine in Adults with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome/AML (MDS/AML) or Myelodysplastic Syndrome with Excess Blasts (MDS-EB)
IRAS ID
1009360
Contact name
Sunil Kadam
Contact email
Sponsor organisation
Apollo Therapeutics, Limited
Clinicaltrials.gov Identifier
Research summary
This study is being done to find out if the investigational drug APL-4098 given alone and/or in combination with azacitidine is safe, tolerable and effective to patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML), myelodysplastic syndrome/AML (MDS/AML) or myelodysplastic syndrome with excess blasts (MBS-EB).
This is a first in human study with 2 parts, Phase 1 and Phase 2. Phase 1 is a dose escalation phase to determine the Recommended Phase 2 Doses (RP2Ds) of APL-4098 while Phase 2 will better define safety, tolerability, response rate, and duration of response up to two dose levels of APL-4098.
An optional evaluation of APL 4098 with azacitidine is also included in both Phase 1 and Phase 2.
APL-4098 will be given orally, once daily in 28-day cycles and azacitidine be dosed as per the label. Participants will take APL-4098 (alone and/or with azacitidine) until relapse/disease progression, unacceptable toxicity, start of new anti-cancer treatment, death or withdrawal of consent.
The study will enroll approximately 122 participants in several countries (approximately 4 research sites in the United Kingdom, 6 research sites in Australia, and 10 research sites in the United States).
Following a screening visit, eligible participants will attend clinic visits on Days -1 (only for participants with intermediate or high risk for TLS and the first participant at each dose level, during Phase 1, up to and including 100 mg for close monitoring for any potential emerging drug related toxicity), 1, 2, 4, 8, 15 and 22 of Cycle 1 and days 1 and 15 of Cycle 2. From Cycle 3 onwards, clinic visits will be on Day 1 only. There will be a safety follow-up visit 28-days after the last dose of AP-4098 and long-term follow up visits once every 3 months.
Study duration is approximately 4 years.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0400
Date of REC Opinion
10 Jan 2025
REC opinion
Further Information Favourable Opinion