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A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

ConditionHigher-risk Myelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkeso

About this trial

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old at the time of enrolment.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

Expected life expectancy ≥ 3 months.

Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of < 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.5.

Disqualifiers

MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic/myeloproliferative neoplasms (MDS/MPN).

Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.

Concurrently participating in another interventional clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

Patients who previously diagnosed with another malignancy and have any evidence of residual disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK117

    Drug

    AK117 IV injection

  • Placebo

    Drug

    Placebo IV injection

  • Azacitidine

    Drug

    Azacitidine SC injection

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: AK117 (dose 1) in combination with azacitidineExperimental treatment 2 interventions
Group B: AK117 (dose 2) in combination with azacitidineExperimental treatment 2 interventions
Group C: Placebo in combination with azacitidinePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Complete remission rate (CRR)

CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria

Time frame
Up to approximately 2 years

Secondary outcomes

1

Overall response rate (ORR)

The proportion of subjects with recorded response per IWG 2023

Time frame
Up to approximately 2 years
2

Time to response (TTR)

Time from the randomization to the first recorded response

Time frame
Up to approximately 2 years
3

Time to CR (TTCR)

Time from the randomization to the first recorded CR

Time frame
Up to approximately 2 years
4

Duration of response (DoR)

Time from the first recorded response until disease relapse or progression or death due to any cause, whichever occurs first

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
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