Investigating APL-4098 with Azacitidine for treating relapsed or refractory AML and high-risk 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)
This study is testing a new treatment called APL-4098, alone and with azacitidine, to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia and high-risk myelodysplastic syndrome.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Apollo Therapeutics Ltd Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (Clayton, Victoria and 6 other locations) |
| Trial ID | NCT06372717 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 1/2 study aims to evaluate the safety, tolerability, and efficacy of APL-4098, both alone and in combination with azacitidine, for patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with excess blasts. The study will include participants who are intolerant to or ineligible for existing therapies. The Phase 1 portion will specifically focus on patients with the MDS-excess blasts subtype. The trial will assess various outcomes to determine the potential benefits of this treatment regimen.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory AML or high-risk MDS who have limited treatment options.
Not a fit: Patients with early-stage AML or MDS who are eligible for standard therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of AML and MDS.
How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/ AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R/R AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit. * WBC count ≤ 25,000/microliter * ECOG Performance Status of ≤ 2 * Weight ≥ 40kg * Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse * Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study * Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial Exclusion Criteria: * Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening * Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening * Diagnostic assessments: Left ventricular ejection fraction \< 45%, Fridericia's corrected QT interval \> 470msec, Aspartate aminotransferase and/or alanine aminotransferase \> 3 x upper limit of normal (ULN), total bilirubin \> 1.5 x ULN, calculated or measured creatinine clearance \< 45 mL/minute (multiply by 0.85 if female) * Infectious disease: HIV positive, active hepatitis B and/or C
Where this trial is running
Clayton, Victoria and 6 other locations
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Hollywood Private Hospital — Nedlands, Western Australia, Australia (Recruiting)
- Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
- The Royal Marsden Hospital — London, United Kingdom (Recruiting)
- Sarah Cannon Research Institute UK — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Apollo Therapeutics
- Email: AP30@apollotx.com
- Phone: 781-479-2267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.