Ivonescimab

Summary

Ivonescimab (CHEMBL6068451) is a phase-3 clinical-stage antibody targeting PDCD1; indicated across 7 conditions including non-small cell lung carcinoma and hepatocellular carcinoma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (PDCD1)
• Indications: 7 conditions
• Clinical trials: 123

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL6068451
Name	Ivonescimab
Type	Antibody
Max phase	3

Also known as: AK-112, Ak112, AK112, Ivonescimab, SMT-112, SMT112, IVONESCIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
PDCD1	programmed cell death 1 (CD279)	Binding		0%	Q15116

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): PDCD1.

Top Reactome pathways

3 total, by targets touching each:

Pathway	Targets	Genes
Co-inhibition by PD-1	1	PDCD1
Potential therapeutics for SARS	1	PDCD1
PD-L1(CD274) glycosylation and translocation to plasma membrane	1	PDCD1

Dominant GO biological processes

GO term	Targets
B cell apoptotic process	1
adaptive immune response	1
negative regulation of tolerance induction	1
negative regulation of T cell mediated immune response to tumor cell	1
negative regulation of B cell apoptotic process	1
apoptotic process	1
humoral immune response	1
negative regulation of inflammatory response	1
regulation of immune response	1
negative regulation of immune response	1
negative regulation of T cell receptor signaling pathway	1
negative regulation of T cell activation	1
positive regulation of T cell apoptotic process	1
regulatory T cell apoptotic process	1
immune system process	1

Indications & clinical

Indications

7 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
non-small cell lung carcinoma	3	MONDO:0005233	EFO:0003060
hepatocellular carcinoma	2	MONDO:0007256	EFO:0000182
small cell lung carcinoma	2	MONDO:0008433	EFO:0000702
triple-negative breast carcinoma	2	MONDO:0005494	EFO:0005537
neoplasm	1	MONDO:0005070	EFO:0000616
colorectal neoplasm	1	MONDO:0005335	MONDO:0005575

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 123.

Phase distribution

Phase	Trials
PHASE2	72
PHASE1/PHASE2	27
PHASE3	13
PHASE1	8
Not specified	2
PHASE4	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06930573	PHASE4	RECRUITING	A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk
NCT05184712	PHASE3	ACTIVE_NOT_RECRUITING	Phase 3 Clinical Study of AK112 for NSCLC Patients
NCT05499390	PHASE3	ACTIVE_NOT_RECRUITING	AK112 in Advanced Non-Small Cell Lung Cancer
NCT05840016	PHASE3	ACTIVE_NOT_RECRUITING	AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
NCT05899608	PHASE3	RECRUITING	Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
NCT06396065	PHASE3	ACTIVE_NOT_RECRUITING	Phase III Study of AK112 for NSCLC Patients
NCT06591520	PHASE3	ACTIVE_NOT_RECRUITING	AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
NCT06767514	PHASE3	RECRUITING	Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
NCT06767527	PHASE3	RECRUITING	AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
NCT06928389	PHASE3	RECRUITING	Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
NCT06951503	PHASE3	RECRUITING	AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
NCT06953999	PHASE3	RECRUITING	A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
NCT07010263	PHASE3	RECRUITING	A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
NCT07264075	PHASE3	RECRUITING	Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN
NCT01042379	PHASE2	RECRUITING	I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT04736823	PHASE2	ACTIVE_NOT_RECRUITING	A Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC
NCT05227664	PHASE2	ACTIVE_NOT_RECRUITING	A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
NCT05229497	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors
NCT05247684	PHASE2	ACTIVE_NOT_RECRUITING	AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
NCT05382442	PHASE2	ACTIVE_NOT_RECRUITING	A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
NCT05582499	PHASE2	RECRUITING	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
NCT05689853	PHASE1/PHASE2	RECRUITING	Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
NCT05846867	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer
NCT05904379	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
NCT06145308	PHASE2	RECRUITING	Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
NCT06196697	PHASE2	RECRUITING	AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer
NCT06196775	PHASE2	NOT_YET_RECRUITING	A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
NCT06472895	PHASE1/PHASE2	NOT_YET_RECRUITING	A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
NCT06478043	PHASE2	NOT_YET_RECRUITING	A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC
NCT06491472	PHASE2	RECRUITING	Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer
NCT06529718	PHASE2	RECRUITING	Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
NCT06530251	PHASE1/PHASE2	RECRUITING	A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT06537011	PHASE2	NOT_YET_RECRUITING	AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT06560112	PHASE2	RECRUITING	An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
NCT06567314	PHASE2	RECRUITING	Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
NCT06646055	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer
NCT06672575	PHASE1/PHASE2	RECRUITING	A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
NCT06684873	PHASE2	NOT_YET_RECRUITING	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)
NCT06760520	PHASE2	NOT_YET_RECRUITING	Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer
NCT06769295	PHASE2	RECRUITING	A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

4 molecules share ≥1 primary target. Top 4 by shared-target count:

Molecule	Source	Status	Shared targets
PYRVINIUM	ChEMBL	Phase 4 (approved)	PDCD1
RIFABUTIN	ChEMBL	Phase 4 (approved)	PDCD1
Gefitinib	PubChem	Approved	PDCD1
Pomalidomide	PubChem	Approved	PDCD1