Ivonescimab Injection

BIOLOGICAL5 trials

Sponsors

Summit Therapeutics, Shanghai Allink Biotherapeutics Co., Ltd., Guangdong Association of Clinical Trials

Conditions

EGFR Mutation-negative and ALK Rearrangement-negativeEastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2NSCLC (Advanced Non-small Cell Lung Cancer)No Prior Systemic Therapy Received for the Advanced or Metastatic DiseaseNon-Small Cell Lung CancerPD-L1 Positive, as Determined by a Validated AssayPatients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC

Phase 2

Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.

Not yet recruitingNCT07603791

Shanghai Allink Biotherapeutics Co., Ltd.NSCLC (Advanced Non-small Cell Lung Cancer)

Start: 2026-06-30End: 2028-12-30Target: 252Updated: 2026-05-22

Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.

Not yet recruitingNCT07742956

Shanghai Allink Biotherapeutics Co., Ltd.NSCLC (Advanced Non-small Cell Lung Cancer)

Start: 2026-08-20End: 2029-12-31Target: 156Updated: 2026-08-03

Phase 3

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

RecruitingNCT05899608

Summit TherapeuticsNon-Small Cell Lung Cancer

Start: 2023-10-26End: 2029-12-31Target: 1600Updated: 2026-08-24

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

RecruitingNCT06767514

Summit TherapeuticsNon-Small Cell Lung Cancer

Start: 2025-02-27End: 2029-06-01Target: 780Updated: 2026-08-19

Unknown Phase

Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study

RecruitingNCT07696832

Guangdong Association of Clinical TrialsPatients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative, Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2 +2

Start: 2026-01-20End: 2027-06-30Target: 265Updated: 2026-07-10

Related Papers

A randomized phase 3 study of ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of metastatic non–small cell lung cancer: HARMONi-3.

Journal of Clinical Oncology2025-05-28

Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors

Journal for ImmunoTherapy of Cancer2024-04-0147 citations