AK117

Phase 3Small molecule

AAkeso

AK117 is one of 317 small molecule programs targeting Advanced Malignant Tumors. It is currently in Phase 3.

Indications

Total Trials

Active Trials

316

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced Malignant TumorsCompleted

Gastroesophageal Junction AdenocarcinomaRecruiting

Triple-Negative Breast CancerActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaRecruiting

Myelodysplastic SyndromesRecruiting

Classic Hodgkin LymphomaRecruiting

Myelodysplastic SyndromeActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

IvonescimabRecruiting

Advanced Malignant TumorsPhase 2

Completed

Gastroesophageal Junction AdenocarcinomaPhase 2

Recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 3

Recruiting

Myelodysplastic SyndromesPhase 2

Recruiting

Classic Hodgkin LymphomaPhase 2

Recruiting

Myelodysplastic SyndromePhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

IvonescimabPhase 2

Recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

34 2

Xospata

Astellas

Phase 3

24 3

Fludara

Sanofi

Phase 3

17 4

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 5

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 6

Vepesid

AAvyxa

Phase 3

52 7

Vanflyta

Daiichi Sankyo

Phase 3

14 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 9

Cerubidine

HHikma Pharmaceuticals LLC

Nexavar

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1/2Not yet recruiting

Acute Myeloid Leukemia

NCT06387420

Phase 2Active, not recruiting

Triple-Negative Breast Cancer

NCT05227664

Phase 1/2Active, not recruiting

Advanced Malignant Tumors

NCT05229497

Q3 2027

Phase 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT06508606

Q4 2027

Phase 3Recruiting

Head and Neck Squamous Cell Carcinoma

NCT06601335

Phase 2Recruiting

Gastroesophageal Junction Adenocarcinoma

NCT05960955

Clinical

Trials by Indication[1]

Advanced Malignant Tumors3 trials

A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors

Unknown status·AAkeso·Phase 1/2·NCT05235542·130 enrolled

A Study of AK112 in Advanced Malignant Tumors

Completed·AAkeso·Phase 1/2·NCT05214482·154 enrolled

A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

Active, not recruiting·AAkeso·Phase 1/2·NCT05229497·154 enrolled

Acute Myeloid Leukemia2 trials

A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Not yet recruiting·AAkeso·Phase 1/2·NCT06387420·180 enrolled

A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia

Active, not recruiting·AAkeso·Phase 1/2·NCT04980885·68 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Recruiting·AAkeso·Phase 3·NCT06601335·510 enrolled

A Study of AK117 (Anti-CD47 Monoclonal Antibody) in Combination With Cetuximab or AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) in Second-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·WWest China Hospital·Phase 2·NCT06508606·20 enrolled

Ivonescimab1 trial

A Study of Ivonescimab in First-Line ES-SCLC

Recruiting·AAkeso·Phase 2·NCT07245446·180 enrolled

Myelodysplastic Syndrome1 trial

A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome

Active, not recruiting·AAkeso·Phase 1/2·NCT04900350·136 enrolled

7 more indications

Myelodysplastic Syndromes1 trial

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

Recruiting·AAkeso·Phase 2·NCT06196203·90 enrolled

Classic Hodgkin Lymphoma1 trial

A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma

Recruiting·AAkeso·Phase 1/2·NCT06642792·280 enrolled

Triple-Negative Breast Cancer1 trial

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

Active, not recruiting·AAkeso·Phase 2·NCT05227664·120 enrolled

Monotherapy1 trial

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104

Completed·AAkesobio Australia Pty Ltd·Phase 1·NCT04349969·38 enrolled

Metastatic Colorectal Cancer1 trial

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Active, not recruiting·AAkeso·Phase 2·NCT05382442·254 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting·AAkeso·Phase 2·NCT05960955·90 enrolled

Phase 11 trial

A Phase 1 Dose Escalation and Expansion Study of AK117

Completed·AAkeso·Phase 1·NCT04728334·49 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for AK117. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AK117 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AK117. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Akeso company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAkeso

AK117

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Advanced Malignant Tumors3 trials

Acute Myeloid Leukemia2 trials

Head and Neck Squamous Cell Carcinoma2 trials

Ivonescimab1 trial

Myelodysplastic Syndrome1 trial

Myelodysplastic Syndromes1 trial

Classic Hodgkin Lymphoma1 trial

Triple-Negative Breast Cancer1 trial

Monotherapy1 trial

Metastatic Colorectal Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Phase 11 trial

References

Drug Info

Quick Facts

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