A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and … (NCT07623187) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and Venetoclax, Compared to Placebo in Combination With Azacitidine and Venetoclax, in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Intensive Chemotherapy
450 participantsStarted 2026-11-01
Plain-language summary
The purpose of this study is to find out how well the study drug IPN60340 works to treat participants with acute myeloid leukemia. Acute myeloid leukemia is a rare blood cancer that grows quickly. This study's main aim is to compare the percentage of participants who reach complete remission within the first 6 months of treatment between the 2 study arms (study drug and standard medicines compared to placebo and standard medicines).
In this study all participants will receive azacitidine and venetoclax plus either the study drug IPN60340 or placebo. Venetoclax will be given as a tablet by mouth once each day in 28-day cycles. Azacitidine will be given by injection under the skin (subcutaneously) or through the veins (intravenously) daily for the first 7 days of each 28-day cycle. IPN60340 or placebo (depending on which arm of the study the participant is assigned to) will be given through the veins (intravenously) on day 1 of each 28-day cycle.
There will be 4 periods in this study:
* A screening period (up to 28 days) to assess whether the participant can take part requiring at least 1 visit to the study center.
* A treatment period where all eligible participants will receive azacitidine and venetoclax plus either the study drug IPN60340 or placebo. The study requires 8 visits for the first month followed by 1 visit every month until unacceptable toxicity, disease progression, the start of new cancer treatment, or study closure, whichever is first.
* A safety follow-up period (at 28 days (±3 days) after the last dose of study medicine) to assess safety after participants have finished treatment.
* A long-term follow-up period where participants' health will be monitored using a telephone call or clinic visit every 12 weeks until the end of study.
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), bone marrow aspirates (sampling of the liquid part of the bone marrow). Some participants will also undergo pregnancy testing. Participants in the Phase 3 portion of the study will also be asked to fill in questionnaires.
The time each participant will be in this study will vary based on how well the medicine works to treat the participant's AML. Azacitidine and venetoclax plus either IPN60340 or placebo will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be 18 years of age or older, at the time of signing the informed consent.
. Have newly diagnosed AML, as per WHO 2022 criteria.
. Eastern Cooperative Oncology Group (ECOG) performance status of 1 to 2 for participants ≥75 years of age, or 1 to 3 for participants \<75 years of age
. Participants must be considered ineligible for intensive chemotherapy, due to age or comorbidities,
. Adequate organ function as indicated in the protocol
. Contraceptive use by participant or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
(Phase 2b and Phase 3) Percentage of participants with Complete Remission (CR)
Timeframe: From randomization to end of Cycle 6 (approximately 6 months)
. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion criteria
. Current diagnosis of:
. History of myeloproliferative neoplasms (MPN) including primary myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia, or MDS/MPN as per WHO 2022 or treatment-related AML
. History of other malignancy within the last 2 years.
. Rapidly progressing disease in the opinion of the clinical investigator which may preclude treatment in this study.
. History of clinically significant or uncontrolled cardiac disorders, within 6 months prior to Cycle 1 Day 1 (C1D1)
. White blood cell (WBC) count \>25 × 10\^9/L . Cytoreduction can be used before C1D1 and beyond as needed to keep WBC \< 25 × 10\^9.
. Participants with severe hepatic impairment, e.g., Child-Pugh C, are excluded.
. Major surgery within 4 weeks prior to C1D1 or planned during the foreseeable duration of the study.