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

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Servier Protocol Code: S227928-180 Sponsor: Servier Bio-Innovation LLC Clinicaltrials.gov Identifier: NCT06563804

Find a recruiting site

How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 16 locations

Study description

This study is needed to test a new drug called S227928 alone or in combination with venetoclax in participants with the following types of blood disorders:

  • Acute Myeloid Leukemia (AML): a cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made).
  • Myelodysplastic Syndrome (MDS): a disorder in which bone marrow does not make enough healthy blood cells.
  • Chronic Myelomonocytic Leukemia (CMML): a rare type of blood cancer.

In leukemia, several proteins prevent cancer cells from dying when they should; two such important proteins are B-Cell Lymphoma 2 (BCL-2) and Myeloid Cell Leukemia 1 (MCL-1). Drugs that block these proteins are a good way to treat patients with leukemia.

S227928 is a new drug which blocks MCL-1 and may help in the treatment of some types of leukemia. Venetoclax is a drug that blocks the action of BCL-2, causing cancer cell death. Venetoclax is currently used to treat AML and other types of leukemia.

The main goal of this study is to find the highest safe and most effective dose of S227928 and to see how well it works when given alone and in combination with venetoclax.

Official title: Phase 1/2 Clinical Trial of S227928, an Anti-CD74 Antibody-Drug Conjugate Targeting MCL-1, as a Single Agent and in Combination With Venetoclax in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML)
Protocol
English (USA)
Conditions
Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS)/AML Chronic Myelomonocytic Leukemia (CMML)
Interventions / Treatments
  • S227928
  • Venetoclax
Other study id numbers
  • S227928-180

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants have to:

  • Be at least 18 years old.
  • Have received at least one prior standard treatment for AML, MDS/AML, or CMML but the disease returned after improvement or did not respond to any treatment.
  • Have adequate kidney, liver and heart function.

Participants cannot take part in the study if they:

  • Have been diagnosed with a type of blood cancer other than AML, MDS or CMML.
  • Had a major surgery within 4 weeks before receiving the study drug or have not recovered from the surgery.
  • Have received anticancer treatment within 2 weeks before receiving the study drug.

How is the study designed?

Allocation
Randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Part 1 Dose Escalation - Arm A

Different doses of S227928 alone are tested to find the highest tolerated dose and/or the recommended dose to give to participants in the dose expansion part.

Intervention / Treatment
Drug: S227928

Participants receive S227928 by infusion (an injection given slowly).

Participant Group / Arm
Experimental: Part 1 Dose Escalation - Arm B

Different doses of S227928 with venetoclax are tested to find the highest tolerated dose and/or the recommended dose to give to participants in the dose expansion part.

Intervention / Treatment
Drug: S227928

Participants receive S227928 by infusion (an injection given slowly).

Drug: Venetoclax

Participants take venetoclax tablets by mouth.

Participant Group / Arm
Experimental: Part 2 Dose Expansion - Cohort 1

Participants with AML or MDS/AML receive the recommended dose of S2279828 in combination with venetoclax.

Intervention / Treatment
Drug: S227928

Participants receive S227928 by infusion (an injection given slowly).

Drug: Venetoclax

Participants take venetoclax tablets by mouth.

Participant Group / Arm
Experimental: Part 2 Dose Expansion - Cohort 2

Participants with CMML receive the recommended dose of S2279828 in combination with venetoclax.

Intervention / Treatment
Drug: S227928

Participants receive S227928 by infusion (an injection given slowly).

Drug: Venetoclax

Participants take venetoclax tablets by mouth.

Keywords

Additional Relevant MeSH Terms Glioma
Recurrence Leukemia, Myeloid, Acute Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic