Trials / Recruiting
RecruitingNCT06372717
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Apollo Therapeutics Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Acute Myeloid Leukemia Refractory
- Myelodysplastic Syndrome Acute Myeloid Leukemia
- Myelodysplastic Syndrome With Excess Blasts
- Acute Myeloid Leukemia, in Relapse
- Acute Myeloid Leukemia (AML)
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-06-04
- Primary completion
- 2027-03-01
- Completion
- 2027-05-01
- First posted
- 2024-04-18
- Last updated
- 2026-02-04
Locations
7 sites across 2 countries: Australia, United Kingdom
Source: ClinicalTrials.gov record NCT06372717. Inclusion in this directory is not an endorsement.