AK112

Phase 3Small molecule

SSummit Therapeutics

AK112 is one of 509 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

508

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerRecruiting

Colorectal CancerActive, not recruiting

Neuroendocrine CancerNot yet recruiting

Advanced Non-Small Cell Lung Cancer (NSCLC)Recruiting

Resectable Non-Small Cell Lung CancerActive, not recruiting

Gallbladder CancerNot yet recruiting

First-Line TreatmentNot yet recruiting

ChemotherapyTerminated

Lung CancerRecruiting

Triple-Negative Breast CancerRecruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

Colorectal CancerPhase 2

Active, not recruiting

Neuroendocrine CancerPhase 2

Not yet recruiting

Advanced Non-Small Cell Lung Cancer (NSCLC)Preclinical

Recruiting

Resectable Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Gallbladder CancerPhase 2

Not yet recruiting

First-Line TreatmentPhase 2

Not yet recruiting

ChemotherapyPhase 2

Terminated

Lung CancerPhase 3

Recruiting

Triple-Negative Breast CancerPhase 3

Recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

AK112

SSummit Therapeutics

Phase 3

4 2

SYS6010

CCSPC Megalith Biopharmaceutical Co.,Ltd.

Phase 3

2 3

Firmonertinib

AAllist Pharmaceuticals, Inc.

Phase 3

2 4

Pemetrexed/carboplatin

AstraZeneca

Phase 3

6 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT05499390

Phase 3Active, not recruiting

Non-Squamous Non-Small Cell Lung Cancer

NCT06396065

Q1 2027

Phase 1/2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05904379

Phase 2Recruiting

Pancreatic Cancer

NCT06944106

Q2 2027

Phase 2Recruiting

Ovarian Cancer

NCT06560112

Phase 1/2Recruiting

Patients With Advanced Solid Tumors

NCT05689853

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment

Not yet recruiting·AAkeso·Phase 2·NCT07158840·60 enrolled

AK112 in Advanced Non-Small Cell Lung Cancer

Active, not recruiting·AAkeso·Phase 3·NCT05499390·398 enrolled

AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

Active, not recruiting·AAkeso·Phase 1/2·NCT05904379·233 enrolled

Show 1 more trial

NEJM-NSCLC: Ivonescimab in PD-L1+ NSCLC

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT04736823·1,050 enrolled

Metastatic Colorectal Cancer3 trials

AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07021950·130 enrolled

AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

Recruiting·AAkeso·Phase 3·NCT06951503·560 enrolled

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Active, not recruiting·AAkeso·Phase 2·NCT05382442·254 enrolled

Ovarian Cancer3 trials

An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer

Recruiting·AAkeso·Phase 2·NCT06560112·172 enrolled

Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer

Recruiting·AAkeso·Phase 2·NCT06686030·150 enrolled

A Study of AK112 Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer

Terminated·AAkeso·Phase 1/2·NCT04999605·8 enrolled

Hepatocellular Carcinoma3 trials

A Study of AK112 in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Completed·AAkeso·Phase 2·NCT05432492·40 enrolled

A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Recruiting·AAkeso·Phase 1/2·NCT06530251·280 enrolled

A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk

Recruiting·TThe First Affiliated Hospital of Zhengzhou University·Phase 4·NCT06930573·30 enrolled

Advanced Solid Tumors2 trials

A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

Completed·AAkesobio Australia Pty Ltd·Phase 1·NCT04047290·80 enrolled

A Study of AK112 for Advanced Solid Tumors

Completed·AAkeso·Phase 1/2·NCT04597541·59 enrolled

22 more indications

Pancreatic Cancer2 trials

A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06944106·30 enrolled

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

Recruiting·AAkeso·Phase 2·NCT07114315·160 enrolled

Bispecific Antibody2 trials

A Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With NSCLC

Completed·AAkeso·Phase 1/2·NCT04900363·108 enrolled

Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC

Completed·AAkeso·Phase 1·NCT05116007·35 enrolled

Advanced Malignant Tumors2 trials

A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

Active, not recruiting·AAkeso·Phase 1/2·NCT05229497·154 enrolled

A Study of AK112 in Advanced Malignant Tumors

Completed·AAkeso·Phase 1/2·NCT05214482·154 enrolled

Colorectal Cancer2 trials

A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases

Not yet recruiting·AAkeso·Phase 1/2·NCT07357220·72 enrolled

A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer

Active, not recruiting·AAkeso·Phase 1/2·NCT05846867·170 enrolled

Chemotherapy2 trials

Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

Terminated·AAkeso·Phase 1/2·NCT05636267·59 enrolled

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

Recruiting·SSichuan University·Phase 2·NCT06769295·28 enrolled

Triple-Negative Breast Cancer2 trials

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

Active, not recruiting·AAkeso·Phase 2·NCT05227664·120 enrolled

AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

Recruiting·AAkeso·Phase 3·NCT06767527·416 enrolled

Lung Cancer1 trial

A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Recruiting·AAkeso·Phase 3·NCT07010263·560 enrolled

Completed·AAkeso·Phase 2·NCT04870177·53 enrolled

Neoadjuvant Therapy1 trial

A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC

Recruiting·TTang-Du Hospital·Phase 1/2·NCT07385001·45 enrolled

First-line Treatment1 trial

A Multicenter, Single-arm, Open-label Study Evaluating the Safety and Efficacy of AK112 Combined With Chemotherapy as First-line Treatment for Non-squamous NSCLC Patients With BRAIN Metastases and Negative Driver Genes (IVO BRAIN)

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06684873·55 enrolled

Patients With Advanced Solid Tumors1 trial

Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors

Recruiting·AAkeso·Phase 1/2·NCT05689853·87 enrolled

AK1121 trial

A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects

Active, not recruiting·AAkeso·Phase 1·NCT07340476·108 enrolled

Biliary Tract Cancer1 trial

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer

Recruiting·AAkeso·Phase 1/2·NCT06938321·135 enrolled

Phase II Clinical Study1 trial

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

Recruiting·AAkeso·Phase 2·NCT07052253·100 enrolled

Leptomeningeal Metastasis1 trial

Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis

Recruiting·GGuangzhou Medical University·Phase 1/2·NCT06809517·34 enrolled

Gallbladder Cancer1 trial

Single-Center, Single-Arm, Two-Stage, Prospective Phase II Clinical Study of AK112 Combined With GAP Regimen as Conversion Therapy for Locally Advanced Gallbladder Cancer

Not yet recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 2·NCT07767994·22 enrolled

Advanced Non-Small Cell Lung Cancer (NSCLC)1 trial

An Open-label, Multicenter Phase Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivonescimab (AK112) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Recruiting·MMultitude Therapeutics Inc.·Preclinical·NCT07590531·118 enrolled

Resectable Non-small Cell Lung Cancer1 trial

Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer

Active, not recruiting·AAkeso·Phase 2·NCT05247684·90 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Active, not recruiting·SSummit Therapeutics·Phase 3·NCT06396065·420 enrolled

Neuroendocrine Cancer1 trial

A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic Digestive System Neuroendocrine Cancer

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07712094·56 enrolled

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for AK112. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AK112 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AK112. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Summit Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSummit Therapeutics

AK112

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Metastatic Colorectal Cancer3 trials

Ovarian Cancer3 trials

Hepatocellular Carcinoma3 trials

Advanced Solid Tumors2 trials

Pancreatic Cancer2 trials

Bispecific Antibody2 trials

Advanced Malignant Tumors2 trials

Colorectal Cancer2 trials

Chemotherapy2 trials

Triple-Negative Breast Cancer2 trials

Lung Cancer1 trial

Second-line Treatment1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Gynecological Tumors1 trial

Neoadjuvant Therapy1 trial

First-line Treatment1 trial

Patients With Advanced Solid Tumors1 trial

AK1121 trial

Biliary Tract Cancer1 trial

Phase II Clinical Study1 trial

Leptomeningeal Metastasis1 trial

Gallbladder Cancer1 trial

Advanced Non-Small Cell Lung Cancer (NSCLC)1 trial

Resectable Non-small Cell Lung Cancer1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Neuroendocrine Cancer1 trial

References

Drug Info

Quick Facts

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