AK117

DRUG15 trials

Sponsors

Akesobio Australia Pty Ltd, Akeso, West China Hospital

Conditions

ACUTE MYELOID LEUKEMIA; AMLAcute Myeloid LeukemiaAdvanced Malignant TumorsClassic Hodgkin LymphomaExtensive-stage Small Cell Lung Cancer (ES-SCLC)Head and Neck Squamous Cell CarcinomaHigher-risk Myelodysplastic SyndromesLocally Advanced Triple-negative Breast Cancer

Phase 1

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

CompletedNCT04349969

Akesobio Australia Pty LtdNeoplasms Malignant

Start: 2020-04-23End: 2022-11-08Updated: 2024-08-21

A Phase 1 Dose Escalation and Expansion Study of AK117

CompletedNCT04728334

AkesoNeoplasms Malignant

Start: 2021-03-23End: 2023-05-12Updated: 2025-03-03

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

Active, not recruitingNCT04900350

AkesoMyelodysplastic Syndrome

Start: 2021-06-18End: 2025-12-31Updated: 2025-03-03

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

Active, not recruitingNCT04980885

AkesoAcute Myeloid Leukemia

Start: 2021-08-13End: 2025-12-31Updated: 2025-03-03

A Study of AK112 in Advanced Malignant Tumors

CompletedNCT05214482

AkesoAdvanced Malignant Tumors

Start: 2022-01-22End: 2025-12-31Updated: 2026-03-03

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

Active, not recruitingNCT05229497

AkesoAdvanced Malignant Tumors

Start: 2022-05-04End: 2027-06-30Target: 154Updated: 2026-03-09

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

AkesoAdvanced Malignant Tumors

Start: 2022-07-12End: 2024-03-31Target: 130Updated: 2022-08-11

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

Not yet recruitingNCT06387420

AkesoACUTE MYELOID LEUKEMIA; AML

Start: 2024-04-29End: 2027-04-30Target: 180Updated: 2024-04-29

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

RecruitingNCT06642792

AkesoClassic Hodgkin Lymphoma

Start: 2025-01-17End: 2028-02-29Target: 280Updated: 2025-02-11

Phase 2

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

Active, not recruitingNCT05227664

AkesoLocally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer

Start: 2022-03-23End: 2027-06-30Target: 120Updated: 2026-03-16

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

Active, not recruitingNCT05382442

AkesoMetastatic Colorectal Cancer

Start: 2022-06-27End: 2028-08-12Target: 254Updated: 2025-10-14

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

RecruitingNCT05960955

AkesoResectable Gastric or Gastroesophageal Junction Adenocarcinoma

Start: 2023-11-13End: 2027-11-30Target: 90Updated: 2023-11-18

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

RecruitingNCT06196203

AkesoHigher-risk Myelodysplastic Syndromes

Start: 2024-02-07End: 2026-06-30Target: 90Updated: 2025-02-11

AK117 (Anti-CD47) + Anti-EGFR for R/M HNSCC

Not yet recruitingNCT06508606

West China HospitalHead and Neck Squamous Cell Carcinoma

Start: 2024-08-01End: 2027-08-01Target: 10Updated: 2024-07-19

A Study of Ivonescimab in First-Line ES-SCLC

RecruitingNCT07245446

AkesoExtensive-stage Small Cell Lung Cancer (ES-SCLC)

Start: 2025-10-29End: 2028-06-30Target: 180Updated: 2025-11-24

Related Papers

A phase II study of AK117 combined with cetuximab or AK104 in the treatment of recurrent or metastatic head and neck squamous cell carcinoma after the failure of PD-1 (L1) inhibitors and/or platinum-based therapy.

Journal of Clinical Oncology2025-05-28

Trial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205)

Blood2024-11-053 citations

The safety and efficacy of ivonescimab in combination with chemotherapy as first-line treatment for advanced biliary tract cancer.

Journal of Clinical Oncology2024-06-014 citations

P431: ACTIVATION OF MACROPHAGE STING ENHANCES PHAGOCYTOSIS OF ACUTE MYELOID LEUKAEMIA

HemaSphere2023-08-01

The safety and efficacy of cadonilimab in combination with AK117 (anti-CD47 antibody) plus chemotherapy as first-line treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer.

Journal of Clinical Oncology2023-06-014 citations

Safety of AK117, an anti-CD47 monoclonal antibody, in patients with advanced or metastatic solid tumors in a phase I study.

Journal of Clinical Oncology2021-05-2017 citations

384 A Phase 1 study to evaluate the safety, PK, and antitumor activity of AK117, an anti-CD47 monoclonal antibody, in subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas

Regular and Young Investigator Award Abstracts2020-11-012 citations