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Pipeline

Ivonescimab Oncology Clinical Trials

Globally over 2,800+ 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 Therapeutics Sub Inc.

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.

Summit Sponsored Ivonescimab Trials
Trial Histology/Population Recruitment Region Phase Status
HARMONi AK112-301 NCT06396065 (opens in new window) 2L advanced EGFRm+ NSCLC ivonescimab + chemo vs. placebo + chemo Global Phase III Active, Not Recruiting
HARMONi-3 SMT112-3003 NCT05899608 (opens in new window) 1L metastatic NSCLC ivonescimab + chemo vs. pembrolizumab + chemo Global Phase III Recruiting
HARMONi-7 SMT112-3007 NCT06767514 (opens in new window) 1L metastatic PD-L1 high (≥50%) NSCLC ivonescimab vs. pembrolizumab Global Phase III Recruiting
Akeso

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.

Akeso Sponsored Ivonescimab Trials
Trial Histology/Population Recruitment Region Phase Status
HARMONi-A AK112-301 NCT05184712 (opens in new window) 2L advanced EGFRm+ NSCLC ivonescimab + chemo vs. placebo + chemo China Phase III Active, Not Recruiting
HARMONi-2 AK112-303 NCT05499390 (opens in new window) 1L metastatic NSCLC (all PD-L1 levels of expression) ivonescimab vs. pembrolizumab China Phase III Active, Not Recruiting
HARMONi-6 AK112-306 NCT05840016 (opens in new window) 1L advanced or metastatic NSCLC ivonescimab + chemo vs. tislelizumab + chemo China Phase III Active, Not Recruiting
HARMONi-8A NCT06928389 (opens in new window) AK112-305 2L advanced or metastatic NSCLC progressed on or after PD-L1 therapy ivonescimab + docetaxel vs. placebo + docetaxel China Phase III Not Yet Recruiting
AK112-201 NCT04736823 (opens in new window) 1L or 2L locally advanced or metastatic NSCLC ivonescimab ± chemo China Phase II Recruiting
HARMONi-9 NCT07010263 (opens in new window) AK112-311 Consolidation treatment SCLC not progressed after chemoradiation ivonescimab vs. placebo China Phase II Not Yet Recruiting
AK112-202 NCT04900363 (opens in new window) 1L or 2L advanced immunotherapy-naïve NSCLC ivonescimab (various doses) China Phase II Active, Not Recruiting
AK112-208 NCT05904379 (opens in new window) 1L advanced or metastatic NSCLC ivonescimab + cadonilimab ± chemo China Phase II Recruiting
HARMONi-BC1 AK112-308 NCT06767527 (opens in new window) 1L inoperable locally advanced/metastatic TNBC ivonescimab + nab-paclitaxel vs. placebo + nab-paclitaxel China Phase III Not Yet Recruiting
AK117-203 NCT05227664 (opens in new window) 1L metastatic TNBC ivonescimab + chemo China Phase II Recruiting
HARMONi-GI1 AK112-309 NCT06591520 (opens in new window) 1L unresectable locally advanced or metastatic BTC ivonescimab + chemo vs. durvalumab + chemo China Phase III Not Yet Recruiting
HARMONi-GI2 AK112-310 NCT06953999 (opens in new window) 1L metastatic PDAC ivonescimab + chemo ± AK117 vs. placebo + chemo China Phase III Not Yet Recruiting
HARMONi-GI6 NCT06951503 (opens in new window) AK112-312 1L metastatic CRC ivonescimab + chemo vs. bevacizumab + chemo China Phase III Not Yet Recruiting
AK112-206 NCT05382442 (opens in new window) 1L metastatic CRC ivonescimab + chemo vs. ivonescimab + ligufalimab + chemo China Phase II Recruiting
AK112-209 NCT06646055 (opens in new window) 1L advanced HCC ivonescimab ± anti-TIGIT antibody ± cadonilimab ± anti-TIGIT/TGF-β vs. sintilimab + bevacizumab China Phase Ib/II Active, Not Recruiting
AK112-210 1L metastatic PDAC cadonilimab +- AK112 +- AG vs. AG China Phase Ib/II Recruiting
AK119-202 NCT05846867 (opens in new window) 1L or 2L microsatellite stable CRC anti-CD73 mAb + ivonescimab +- chemo China Phase Ib/II Recruiting
AK130-201 NCT06938321 (opens in new window) 2L advanced BTC ivonescimab +-anti-TIGIT/TGF-β or ivonescimab China Phase Ib/II Not Yet Recruiting
HARMONi-HN1 AK117-302 NCT06601335 (opens in new window) 1L recurrent or metastatic HNSCC with PD-L1 positive (CPS ≥1) ivonescimab + AK117 vs. placebo + pembrolizumab China Phase III Recruiting
AK117-201 NCT05229497 (opens in new window) Recurrent or metastatic HNSCC ivonescimab ± AK117 ± chemo China Phase Ib/II Recruiting
AK104-221 NCT06560112 (opens in new window) 2L OC ivonescimab ± chemo ± cadonilimab China Phase II Recruiting
AK112-211 NCT06686030 (opens in new window) 1L platinum-sensitive OC ivonescimab +- chemo +- olaparib China Phase II Recruiting
AK127-104 NCT05951608 (opens in new window) 1L advanced malignant tumors ivonescimab + anti-TIGIT antibody China Phase Ib/II Not Yet Recruiting
AK117-202 NCT05214482 (opens in new window) 1L or 2L advanced or metastatic NSCLC, GEJ, BTC, PDAC ivonescimab + ligufalimab ± chemo China Phase Ib/II Active, Not Recruiting

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

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

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