drugset
Drugs / AK117
last change Aug 2026 re-read 9 days ago

AK117

Monoclonal antibody targets CD47

Developed for
cancer · acute myeloid leukemia · head and neck squamous cell carcinoma · myelodysplastic syndrome · classic Hodgkin lymphoma · colorectal cancer · gastroesophageal adenocarcinoma · malignant pancreatic neoplasm
+2 more · small cell lung carcinoma · triple-negative breast carcinoma
Investigated by
Akeso · Akeso Biopharma, Inc. · Summit Therapeutics · West China Hospital

Trials 17

today NCT07245446 · Ph 2 NCT06953999 · Ph 3 NCT06642792 · Ph 1/2 NCT06601335 · Ph 3 NCT06508606 · Ph 2 NCT06387420 · Ph 1/2 NCT06196203 · Ph 2 NCT05960955 · Ph 2 NCT05382442 · Ph 2 NCT05229497 · Ph 1/2 NCT05227664 · Ph 2 NCT05235542 · Ph 1/2 NCT05214482 · Ph 1/2 NCT04980885 · Ph 1/2 NCT04900350 · Ph 1/2 NCT04728334 · Ph 1 NCT04349969 · Ph 1
20212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT04728334 Mar 2021 → Jan 2022 cancer Akeso Completed No outcome recorded
Phase 1 NCT04349969 Apr 2020 → Nov 2022 cancer Akeso Biopharma, Inc. Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT06642792 Jan 2025 → Nov 2027 expected classic Hodgkin lymphoma Akeso Recruiting No outcome recorded
Phase 1/2 NCT06387420 Apr 2024 → Apr 2026 overdue acute myeloid leukemia Akeso Not yet recruiting No outcome recorded
Phase 1/2 NCT05229497 May 2022 → Dec 2026 expected cancer Akeso Active not recruiting No outcome recorded
Phase 1/2 NCT05235542 Mar 2022 → May 2026 cancer Akeso Completed No outcome recorded
Phase 1/2 NCT05214482 Jan 2022 → Nov 2025 cancer Akeso Completed No outcome recorded
Phase 1/2 NCT04980885 Aug 2021 → Sep 2025 overdue acute myeloid leukemia Akeso Active not recruiting No outcome recorded
Phase 1/2 NCT04900350 Jun 2021 → Sep 2025 overdue myelodysplastic syndrome Akeso Active not recruiting No outcome recorded
Phase 26 trials
Phase 2 NCT07245446 Oct 2025 → Dec 2027 expected small cell lung carcinoma Akeso Recruiting No outcome recorded
Phase 2 NCT06508606 Aug 2024 → Aug 2026 overdue head and neck squamous cell carcinoma West China Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06196203 Feb 2024 → Jan 2026 overdue myelodysplastic syndrome Akeso Recruiting No outcome recorded
Phase 2 NCT05960955 Nov 2023 → Nov 2024 overdue gastroesophageal adenocarcinoma Akeso Recruiting No outcome recorded
Phase 2 NCT05382442 Jun 2022 → May 2026 overdue colorectal cancer Akeso Active not recruiting No outcome recorded
Phase 2 NCT05227664 Mar 2022 → Dec 2026 expected triple-negative breast carcinoma Akeso Active not recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT06953999 Jun 2025 → May 2027 expected malignant pancreatic neoplasm Akeso Recruiting No outcome recorded
Phase 3 NCT06601335 Oct 2024 → Jan 2027 expected head and neck squamous cell carcinoma Akeso Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2026-06-17 Akeso Results 口头报告 | 康方莱法利单抗(CD47)联合方案治疗AML随机双盲对照 II 期研究数据在EHA 2026重磅发布 akesobio.com ↗
莱法利单抗组无事件生存期(EFS)达 9.1 个月(vs 对照组6.9个月)，风险比 (HR)=0.46；6个月EFS 率为67.8% (vs 对照组55.5%)，9个月EFS率53.2% (vs对照组14.1%).
2026-05-14 Akeso Results 口头报告|康方生物莱法利单抗（CD47）联合方案治疗初诊AML 的随机双盲对照 II期数据在EHA 2026重磅发布 akesobio.com ↗
研究结果显示，莱法利单抗联合维奈克拉和阿扎胞苷治疗AML初治患者展现出令人鼓舞的疗效，可显著提升患者生存获益，为难以承受强化疗的AML患者带来更优安全性的潜在治疗方案.
2025-09-16 Akeso Regulatory 康方生物CD47单抗获得FDA孤儿药资格认定！ akesobio.com ↗
近日，美国食品药品监督管理局（FDA）授予了康方生物（9926.HK）自主研发的新一代抗CD47人源化IgG4单克隆抗体莱法利单抗（AK117）孤儿药资格认定（Orphan Drug Designation，ODD），适应症为急性髓系白血病（AML）.
2024-09-18 Akeso Results ESMO2024 丨 有望填补mCRC免疫治疗空白！依沃西与莱法利联合方案II期优异数据发表 akesobio.com ↗
研究显示，两组一线治疗MSS/pMMR型mCRC均具有高效的抗肿瘤活性，疾病控制高效，初步远期疗效令人满意，且依沃西联合莱法利单抗后的抗肿瘤疗效更佳.
2024-09-06 Akeso Results ESMO 2024 | 多项Oral发布:康方生物卡度尼利、依沃西、莱法利等13项重磅研究成果发表 akesobio.com ↗
2024-01-16 Akeso Regulatory 康方生物CD47单抗AK117联合AZA和VEN治疗AML三联疗法获批临床 akesobio.com ↗
近日，康方生物（9926.HK）独立自主研发的新一代CD47单抗（AK117）联合维奈克拉（VEN）联合阿扎胞苷（AZA）治疗初治不适合标准诱导化疗的急性髓系白血病（AML）患者的Ⅱ期临床试验申请已获得国家药品监督管理局药品审评中心批准.
2023-12-14 Akeso Results ASH 2023丨 康方生物CD47单抗联合阿扎胞苷治疗较高危MDS的积极研究结果发布 akesobio.com ↗
结果显示，AK117联合阿扎胞苷协同治疗减少了新诊断较高危MDS患者的贫血及输血需求，展现了良好的安全性和显著的有效性，有望成为全球MDS患者更优的治疗选择.
2023-11-16 Akeso Results ASH 2023丨康方生物CD47单抗AK117两项研究成果将公布 akesobio.com ↗
结果显示，AK117和AZA的联合治疗表现出安全性易于管理，贫血发生率低，并且在无法接受强化化疗的AML患者中显示出富有临床潜力的一线治疗效果.
2023-09-26 Akeso Regulatory 康方生物CD47单抗美国临床获批开展！ akesobio.com ↗
近日，康方生物（9926.HK）宣布，公司自主研发的新一代CD47单抗（AK117）联合阿扎胞苷治疗初诊较高危骨髓增生异常综合征（MDS）的随机、双盲、全球多中心II期临床研究申请，已获得美国食品药品监督管理局（FDA）批准.
2022-12-12 Akeso Results 康方CD47单抗机制研究成果在《癌症免疫治疗杂志》发表 akesobio.com ↗
AK117不会诱导人红细胞的血凝反应，且直到3000nmol/L仍不会引起人红细胞凝集；相比之下，Hu5F9-G4在浓度≥4.1nmol/L就会诱导人红细胞凝集.
2022-01-10 Akeso Regulatory CD47单抗（AK117）联合PD-1/VEGF双抗（AK112）联合或不联合化疗治疗恶性肿瘤的Ib/II临床研究获批开展 akesobio.com ↗
已经获得国家药品监督管理局药品审评中心（CDE）批准，开展联合或不联合化疗治疗晚期恶性肿瘤的Ib/II期临床研究
2021-10-11 Akeso Regulatory 康方生物AK112（PD-1/VEGF双抗）联合AK117（CD47单抗）获批开展治疗恶性肿瘤的临床研究 akesobio.com ↗
【香港讯，2021年10月11日】康方生物（9926.HK）宣布，公司核心自主研发的新型肿瘤免疫治疗药物AK112（PD-1/VEGF双特异性抗体）联合AK117（CD47单抗），已经获得国家药品监督管理局药品审评中心（CDE）批准，开展治疗晚期恶性肿瘤的Ib/II期临床研究.

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

FieldValueCited text
Known as AK117 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04900350 ↗
16

NCT05382442 ↗

NCT05960955 ↗

NCT06601335 ↗

NCT06387420 ↗

NCT06196203 ↗

NCT06508606 ↗

NCT05214482 ↗

NCT04349969 ↗

NCT05235542 ↗

NCT05229497 ↗

Show 6 more sources
Action Inhibit “AK117#Anti-CD47 Antibody#” NCT05229497 ↗
Modality Monoclonal antibody “AK117 (Anti-CD47 Monoclonal Antibody)” NCT06642792 ↗
Route Intravenous “AK117 monotherapy intravenous (IV) infusion- weekly doses in a 28-day cycle.” NCT04349969 ↗
Target CD47 “AK117 (Anti-CD47)” NCT04900350 ↗