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RECRUITING Phase 2

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

NCT06196203 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG Placebo
  • DRUG Azacitidine
  • DRUG AK117

Study Locations (15)

Maryland

  • American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda) — Bethesda
  • Maryland Oncology-Columbia — Columbia

Ohio

  • Gabrail Cancer Center — Canton
  • Ohio State University — Columbus

California

  • UCLA Ronald Reagan Medical Center — Los Angeles

Colorado

  • Rocky Mountain Cancer Centers — Aurora

Connecticut

  • Yale Cancer Center — New Haven

Florida

  • Mid Florida Hematology and Oncology Center — Orange City

Missouri

  • Washington University School of Medicine in St. Louis — St Louis

New York

  • Montefiore Einstein Comprehensive Cancer Center — The Bronx

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-02-07
Est. Completion 2026-06
Phase Phase 2

Sponsor

Akeso

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06196203

The ClinicalTrials.gov registry entry for NCT06196203 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akeso, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Higher-risk Myelodysplastic Syndromes appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06196203 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Maryland, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06196203 about?

NCT06196203 is a clinical study titled "A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes". 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).

What is the current status of trial NCT06196203?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-02-07. Estimated completion is 2026-06.

What conditions does trial NCT06196203 study?

This clinical trial studies the following conditions: Higher-risk Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06196203?

The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), AK117 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06196203?

This trial is sponsored by Akeso, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06196203 being conducted?

This trial has 15 study locations across California, Colorado, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial