SAR443579 + Other Agents for Blood Cancers

Recruiting at 7 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must not be taking: Antiretrovirals, CYP3A inducers

Disqualifiers: Uncontrolled conditions, Second malignancy, AIDS, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or adult participants with CD123 expressing hematological malignancies. This protocol is structured as a master protocol (containing common protocol elements). Individual sub-studies will explore SAR443579 with combination partners, which may include approved or investigational agents. Experimental sub-studies will be tested through 3 parts: Part 1: dose finding (such as dose escalation/ safety run-in). Part 2: dose optimization (when applicable). Part 3: dose expansion. In each sub-study, a dose escalation will identify preliminary recommended dose for expansion (pRDE) of SAR443579 and its respective combination partner. Following the determination of the preliminary RDE, additional participants will be enrolled in the dose expansion part, or if dose optimization needs to be further evaluated, additional participants will be enrolled in the "dose optimization/expansion" part. Dose optimization and dose expansion part could involve randomization depending on specific sub-study design. Study will consist of a screening period, treatment period, and follow-up period. Participants will receive study treatment until documented disease progression, unacceptable adverse events, participant's decision to stop study treatment, or completion of the maximum cycles allowed in the sub-studies, or the participant meets other criteria for discontinuation per study protocol (whichever occurs first).

Do I need to stop my current medications to join the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that you should not be on medications with a narrow therapeutic index that are substrates of CYP enzymes unless they can be closely monitored for dose adjustment. Also, you should not have taken strong or moderate CYP3A inducers within 7 days before starting the study treatment.

Eligibility Criteria

This trial is for adolescents and adults with blood cancers, specifically those expressing CD123, who are seeking new treatments. Participants should be eligible based on specific inclusion criteria not detailed here.

Inclusion Criteria

My liver is functioning well.

I am not a candidate for intensive chemotherapy.

No predicted life expectancy ≤3 months

Exclusion Criteria

I have been treated with specific medications before starting the study treatment.

I do not have any uncontrolled medical conditions.

I have not had any other cancer that is getting worse or needed treatment in the last 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction and Maintenance

Participants receive SAR443579 in combination with azacitidine and venetoclax for dose finding, optimization, and expansion

Up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• SAR443579

Trial Overview The study tests SAR443579 combined with other agents like azacitidine or venetoclax in a multi-phase approach to determine safety and effectiveness. It includes dose finding, optimization, and expansion across different cohorts.

Participant Groups

Group I: Substudy 01: SAR443579 + azacitidine + venetoclax Experimental Treatment 3 Interventions

Part 1: Safety run-in: SAR443579 treatment will begin with an identified starting dose. Safety run-in will proceed according to the incidence of DLTs.

SAR443579 is already approved in United States, European Union for the following indications:

Approved in United States as SAR443579 for:

• None approved; received FDA Fast Track Designation for the treatment of acute myeloid leukemia

Approved in European Union as SAR443579 for:

• None approved; currently in clinical trials

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University