TerminatedPhase 1/2

A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML

Stopped: Sponsor decision

United States, Australia, Finland13 participantsStarted 2025-02-25

Plain-language summary

The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this combination. The study will begin as a Phase 1 Dose Escalation study to determine the RP2D and then will transition to a Phase 2 Dose Expansion study to assess the efficacy of the selected RP2D. During the treatment period participants will have study visits every two weeks, with additional visits occurring during the first and second cycle. Approximately 30 days after treatment has ended, an end-of-treatment visit will occur and then participants will be followed for survival every 12 weeks for the next 6 months. Study visits may include a bone marrow aspirate and/or biopsy, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.

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

. Patients must not be candidates for further standard therapy,
. Treatment with agents for lower risk MDS such as erythropoietin or luspatercept are not considered anticancer therapies.
. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN),
. Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who may be included if their total bilirubin is ≤ 3.0 x ULN and their direct bilirubin is ≤ 1.5 x ULN.

Exclusion criteria

. CD4+ T-cell (CD4+) counts \< 350 cells/µL
. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening

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

Dose Escalation: Number and severity of Dose Limiting Toxicities (DLTs)

Timeframe: Through Cycle 1 (each cycle is 28 days)

Dose Escalation: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Through 30 days after the end of treatment (Approximately 3.5 years)

Dose Escalation: Number of dose reductions, interruptions, delays, or study withdrawal due to AEs

Timeframe: Through 30 days after the end of treatment (Approximately 3.5 years)

Dose Expansion: Complete remission (CR)

Timeframe: Through 6 months after the end of treatment (Approximately 4 years)

Trial details

NCT IDNCT06563804

SponsorServier Bio-Innovation LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-09

View on ClinicalTrials.gov More Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) trials

Plain-language summary

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

. Patients must not be candidates for further standard therapy,
. Treatment with agents for lower risk MDS such as erythropoietin or luspatercept are not considered anticancer therapies.
. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN),
. Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who may be included if their total bilirubin is ≤ 3.0 x ULN and their direct bilirubin is ≤ 1.5 x ULN.

Exclusion criteria

. CD4+ T-cell (CD4+) counts \< 350 cells/µL
. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening

What they're measuring

Dose Escalation: Number and severity of Dose Limiting Toxicities (DLTs)

Timeframe: Through Cycle 1 (each cycle is 28 days)

Dose Escalation: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Through 30 days after the end of treatment (Approximately 3.5 years)

Dose Escalation: Number of dose reductions, interruptions, delays, or study withdrawal due to AEs

Timeframe: Through 30 days after the end of treatment (Approximately 3.5 years)

Dose Expansion: Complete remission (CR)

Timeframe: Through 6 months after the end of treatment (Approximately 4 years)