Ivonescimab Oncology Clinical Trials

Globally over 1,800+ 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 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
EGFR Mutant Positive Second-line Advanced or Metastatic Who Have Progressed Following EGFR-TKI Combination: ivonescimab + chemotherapy vs. placebo + chemotherapy
Recruitment Region
United States
Status (Phase)
Phase III
Trial
HARMONi-3NCT05899608
Histology / Population
First-line Metastatic Combination: ivonescimab + chemotherapy vs. pembrolizumab + chemotherapy
Recruitment Region
United States
Status (Phase)
Phase III
Trial
HARMONi-7NCT06767514
Histology / Population
First-line Metastatic Monotherapy: ivonescimab vs. pembrolizumab​
Recruitment Region
United States
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
AK112-301NCT05184712
Histology / Population
2L+ Non-squamous NSCLC EGFRm+ after a TKI Randomized: ivonescimab + chemotherapy vs. placebo + chemotherapy
Recruitment Region
China
Status (Phase)
Phase III
Trial
AK112-303NCT05499390
Histology / Population
NSCLC Stage IIIb/c or IV, TPS ≥1%, First-line Monotherapy: ivonescimab vs. Pembrolizumab
Recruitment Region
China
Status (Phase)
Phase III
Trial
AK112-306NCT05840016
Histology / Population
NSCLC Stage IIIb/c or IV, First-line Combination ivonescimab + chemotherapy vs. Tislelizumab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase III
Trial
SMT112-3003NCT05899608
Histology / Population
1L Squamous NSCLC Randomized: ivonescimab + chemotherapy vs pembrolizumab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase III
Trial
AK112-201NCT04736823
Histology / Population
Squamous / Non-squamous First-line, EGFR-TKI, or Immunotherapy + Chemotherapy Relapsed Combination ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK112-203NCT04870177
Histology / Population
Advanced Gynecological Tumors Monotherapy: ivonescimab
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK112-205NCT05247684
Histology / Population
Neoadjuvant / Adjuvant Resectable NSCLC Monotherapy: ivonescimab / Combination AK112 + 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 / Monotherapy ivonescimab
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK117-203NCT05227664
Histology / Population
Locally Advanced or Metastatic Triple-negative Breast Cancer Combination: Ak117 + ivonescimab + chemotherapy, AK117 + chemotherapy, ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase II
Trial
AK112-202NCT04900363
Histology / Population
NSCLC Stage IIIb/c, First- or Second-line Therapy Monotherapy: ivonescimab
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK112-208NCT05904379
Histology / Population
NSCLC Stage IIIb/c or IV Combination: ivonescimab +AK104 , ivonescimab + AK104 + chemotherapy
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK117-201NCT05229497
Histology / Population
Advanced Malignant Tumors, and Head & Neck Squamous Carcinoma Combination: ivonescimab + AK117, ivonescimab + AK117 + chemotherapy / Monotherapy ivonescimab
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK117-202NCT05214482
Histology / Population
Advanced Malignant Tumors, and First-line Gastric / Gastroesophageal Junction, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma, and Non-squamous EGFR-TKI Relapsed Combination: ivonescimab + AK117, ivonescimab + chemotherapy + AK117
Recruitment Region
China
Status (Phase)
Phase Ib/II
Trial
AK112-102NCT04597541
Histology / Population
Advanced Solid Tumors Monotherapy: ivonescimab
Recruitment Region
China
Status (Phase)
Phase I/II
Trial
AK112-101NCT04047290
Histology / Population
Advanced Solid Tumors Monotherapy: ivonescimab
Recruitment Region
Australia
Status (Phase)
Phase Ia/Ib
Trial
AK112-103NCT05116007
Histology / Population
Extensive Stage–Small-cell Lung Cancer Combination ivonescimab + chemotherapy
Recruitment Region
China
Status (Phase)
Phase Ib

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