S227928 + Venetoclax for Leukemia

Recruiting at 15 trial locations

Overseen By Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Servier Bio-Innovation LLC

Must not be taking: QT prolonging drugs

Disqualifiers: Pregnancy, MPNs, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with certain types of blood cancers like AML, MDS/AML, or CMML who have already tried at least one standard treatment and it didn't work (relapsed/refractory). They should be in a decent physical state (ECOG ≤ 2), able to follow strict birth control guidelines if they can have children, and not eligible for more standard treatments. Their blood counts and liver/kidney functions need to meet specific levels.

Inclusion Criteria

My white blood cell count is below 10 x 109/L.

I cannot receive any more standard treatments.

I have taken treatments like erythropoietin or luspatercept for MDS, but not cancer therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1 Dose Escalation study to determine the recommended Phase 2 dose (RP2D) of S227928 as a single agent and in combination with venetoclax

Varies

Study visits every two weeks, with additional visits during the first and second cycle

Dose Expansion

Phase 2 Dose Expansion study to assess the efficacy of the selected RP2D of S227928 in combination with venetoclax

Varies

Study visits every two weeks

Follow-up

Participants are monitored for survival every 12 weeks for the next 6 months after the end of treatment

6 months

Treatment Details

Interventions

• S227928
• Venetoclax

Trial Overview The study tests S227928 alone and combined with Venetoclax to see how safe they are, how well they work against leukemia, and what the best dose might be. It starts by finding the right dose (Phase 1) then checks its effectiveness (Phase 2). Participants will visit every two weeks for various health checks including bone marrow tests.

Participant Groups

Group I: Dose Expansion - Cohort 2 Experimental Treatment 2 Interventions

For participants with CMML. S227928 in combination with venetoclax at RP2D

Group II: Dose Expansion - Cohort 1 Experimental Treatment 2 Interventions

For participants with R/R AML and MDS/AML. S227928 in combination with venetoclax at RP2D

Group III: Dose Escalation - Arm B Experimental Treatment 2 Interventions

S227928 in combination with venetoclax

Group IV: Dose Escalation - Arm A Experimental Treatment 1 Intervention

S227928 as a single agent

Who Is Running the Clinical Trial?

Servier Bio-Innovation LLC

Lead Sponsor

Trials

9

Recruited

670+