NCT06387420

A Phase 1b/2 Study of AK117 (Anti-CD47 Antibody) in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Not yet recruiting Phase 1/Phase 2 Last updated 24 April 2024

What this trial tests

Phase 1/Phase 2 trial testing AK117 in ACUTE MYELOID LEUKEMIA; AML in 180 participants. Not yet recruiting.

Timeline

29 April 2024

Primary endpoint
1 April 2026

1 April 2027

Quick facts

Lead sponsor	Akeso
Phase	Phase 1/Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	180
Start date	29 April 2024
Primary completion	1 April 2026
Estimated completion	1 April 2027
Sites	1 location across China

Drugs / interventions tested

• AK117 — full drug profile →
• Azacitidine (azacitidine) — full drug profile →
• Venetoclax (venetoclax) — full drug profile →
• Placebo

Conditions studied

• ACUTE MYELOID LEUKEMIA; AML — all drugs for ACUTE MYELOID LEUKEMIA; AML →

Sponsor

Akeso — full company profile →

Who can join

18 and older, any sex, with ACUTE MYELOID LEUKEMIA; AML. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Phase 1b: Number of participants with dose limiting toxicity (DLT)
  Time frame: At the end of Cycle 1 (each cycle is 28 days)
  Any untoward medical occurrence in a subject within the first cycle, considered related to the study treatment
• Phase 1b/2: Number of participants with adverse events (AEs)
  Time frame: Up to approximately 2 years.
  Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment
• Phase 1b/2: Composite complete remission rate (CCR)
  Time frame: Time Frame: Up to approximately 2 years
  The proportion of subjects achieving complete remission (CR) , complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2022 criteria

Sponsor's own description

This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting acute myeloid leukemia through antibody engineering: innovations in immunotherapy and combination regimens.
   Soleimani Samarkhazan H, Noormohamadi H, Shafiei FS, Taghinejad Z, et al · · 2025 · cited 15× · PMID 40550903 · DOI 10.1007/s10238-025-01764-2
2. The AML immune paradox: decoding escape pathways and pioneering checkpoint, vaccine, and combination strategies.
   Soleimani Samarkhazan H, Shafiei FS, Taghinejad Z, Maleknia M, et al · · 2025 · cited 14× · PMID 40634759 · DOI 10.1007/s10238-025-01795-9
3. Unraveling Venetoclax Resistance: Navigating the Future of HMA/Venetoclax-Refractory AML in the Molecular Era.
   Chatzilygeroudi T, Karantanos T, Pappa V. · · 2025 · cited 9× · PMID 40361510 · DOI 10.3390/cancers17091586
4. Comprehensive view on chemotherapy-free management of acute myeloid leukemia by using venetoclax in combination with targeted and/or immune therapies.
   Kegyes D, Tat A, Vizitiu AS, Vazar-Tripon D, et al · · 2025 · cited 6× · PMID 40804253 · DOI 10.1038/s41420-025-02678-4
5. Macrophages as Potential Therapeutic Targets in Acute Myeloid Leukemia.
   Mesaros O, Onciul M, Matei E, Joldes C, et al · · 2024 · cited 4× · PMID 39457618 · DOI 10.3390/biomedicines12102306
6. Metabolic reprogramming of efferocytosis in the tumour microenvironment: From apoptotic-cell clearance to therapeutic targeting.
   Yang Q, Yan J, Yang Q. · · 2026 · cited 1× · PMID 41601343 · DOI 10.1002/ctm2.70601