Ivonescimab Oncology Clinical Trials

Globally over 2,300+ have been treated with ivonescimab across all clinical trials to date.

Summit License Territories: United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa.

Akeso License Territories: Rest of World
All Akeso ivonescimab clinical trials are being conducted in China and/or Australia and are fully sponsored and managed by Akeso.
Learn more about our partnership with Akeso, Inc. here.

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Summit Sponsored Ivonescimab Trials: Ivonescimab is currently being investigated in global Phase III clinical trials. Phase I and II were completed by our partner Akeso. This pipeline reflects clinical trials that have been announced.

Trial
Histology/Population
Recruitment Region
Status (Phase)
Trial
HARMONiAK112-301NCT06396065
Histology / Population
NSCLC: EGFR Mutant Positive Second-line Advanced or Metastatic Who Have Progressed Following EGFR-TKI Combination: ivonescimab + chemotherapy vs. placebo + chemotherapy
Recruitment Region
Global
Status (Phase)
Phase III
Trial
HARMONi-3SMT112-3003NCT05899608
Histology / Population
NSCLC: First-line Metastatic Combination: ivonescimab + chemotherapy vs. pembrolizumab + chemotherapy
Recruitment Region
Global
Status (Phase)
Phase III
Trial
HARMONi-7SMT112-3007NCT06767514
Histology / Population
NSCLC: First-line Metastatic Monotherapy: ivonescimab vs. pembrolizumab​
Recruitment Region
Global
Status (Phase)
Phase III

Akeso Sponsored Ivonescimab Trials
All Akeso ivonescimab clinical trials are being conducted in China and/or Australia and are fully sponsored and managed by Akeso.

Trial
Histology/Population
Recruitment Region
Status (Phase)
Trial
HARMONi-AAK112-301NCT05184712
Histology / Population
NSCLC: 2L+ NSQ NSCLC EGFRm+ after a TKI Randomized: ivonescimab + chemotherapy vs. placebo + chemotherapy
Recruitment Region
China
Status (Phase)
Phase III
Trial
HARMONi-2AK112-303NCT05499390
Histology / Population
NSCLC: Stage IIIb/c or IV, TPS ≥1%, First-line Randomized: ivonescimab vs. Pembrolizumab
Recruitment Region
China
Status (Phase)
Phase III
Trial
HARMONi-6AK112-306NCT05840016
Histology / Population
NSCLC: Stage IIIb/c or IV, First-line Randomized: ivonescimab + chemotherapy vs. Tislelizumab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase III
Trial
HARMONi-BC1AK112-308NCT06767527
Histology / Population
1L Triple Negative Breast Cancer (TNBC) ivonescimab vs. ivonescimab + nab-paclitaxel
Recruitment Region
China
Status (Phase)
Phase III
Trial
HARMONi-GI1AK112-309NCT06591520
Histology / Population
1L Biliary Tract Cancer (BTC) Randomized: ivonescimab + chemotherapy vs. durvalumab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase III
Trial
HARMONi-GI2AK112-310
Histology / Population
1L Pancreatic Cancer (PDAC) Randomized: ivonescimab + Ligufalimab + AG vs. ivonescimab + AG
Recruitment Region
China
Status (Phase)
Phase III
Trial
HARMONi-HN1AK117-302NCT06601335
Histology / Population
1L R/M HNSCC, PD-L1 CPS ≥1% Randomized: Combination AK112 + AK117 vs. Pembrolizumab
Recruitment Region
China
Status (Phase)
Phase III
Trial
AK112-201NCT04736823
Histology / Population
1L SQ and NSQ NSCLC Combination: ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK112-205NCT05247684
Histology / Population
Neoadjuvant / Adjuvant Resectable NSCLC ivonescimab, ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK112-206NCT05382442
Histology / Population
Metastatic Colorectal Cancer Combination: ivonescimab + AK117 + XELOX or FOLFOXIRI, ivonescimab + chemotherapy, ivonescimab + AK117 + chemotherapy, ivonescimab + AK117, ivonescimab + chemotherapy, monotherapy ivonescimab
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK117-203NCT05227664
Histology / Population
Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC) Combination: AK117 + ivonescimab + chemotherapy, AK117 + chemotherapy, ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK104-221NCT06560112
Histology / Population
Recurrent Ovarian Cancer Combination: AK104 + ivonescimab, AK104 + chemotherapy, ivonescimab + chemotherapy, ivonescimab + chemotherapy + AK104
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK112-202NCT04900363
Histology / Population
Advanced NSCLC PD-L1 TPS ≥1 Monotherapy: ivonescimab
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK112-208NCT05904379
Histology / Population
Advanced NSCLC Combination: ivonescimab + AK104, ivonescimab + AK104 + chemotherapy, chemotherapy alone
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK117-201NCT05229497
Histology / Population
Head & Neck Squamous Carcinoma Combination: ivonescimab + AK117, ivonescimab monotherapy, ivonescimab + AK117 + chemotherapy
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK117-202NCT05214482
Histology / Population
Gastroesophageal Junction, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma Combination: ivonescimab + AK117, ivonescimab + chemotherapy + AK117, ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK127-104NCT05951608
Histology / Population
Advanced Solid Tumors Combination: AK127 + AK112
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK112-209NCT06530251
Histology / Population
Hepatocellular Carcinoma Combination: ivonescimab + AK130, ivonescimab + AK127, ivonescimab + AK104, ivonescimab. Active comparator: sintilimab + in combination with bevacizumab
Recruitment Region
China
Status (Phase)
Phase Ib/II

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than
China’s National Medical Products Administration (NMPA)