Izalontamab

Summary

Izalontamab (CHEMBL5095384) is a phase-3 clinical-stage antibody; indicated across 5 conditions including head and neck squamous cell carcinoma and neoplasm.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 5 conditions
• Clinical trials: 11

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5095384
Name	Izalontamab
Type	Antibody
Max phase	3

Also known as: Her3 x egfr si-b001, Izalontamab, Si b001, SI-B001, IZALONTAMAB

Targets

Targets

No target linkage available.

Bioactivity

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

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

5 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
head and neck squamous cell carcinoma	2	MONDO:0010150	EFO:0000181
neoplasm	2	MONDO:0005070	EFO:0000616
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
esophageal squamous cell carcinoma	2	MONDO:0005580	EFO:0005922
colorectal neoplasm	2	MONDO:0005335	MONDO:0005575

Clinical trials

Total trials: 11.

Phase distribution

Phase	Trials
PHASE2	6
PHASE1/PHASE2	2
PHASE2/PHASE3	1
PHASE3	1
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05020769	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.
NCT05943795	PHASE3	ACTIVE_NOT_RECRUITING	A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma
NCT05020457	PHASE2	ACTIVE_NOT_RECRUITING	SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.
NCT05022654	PHASE2	ACTIVE_NOT_RECRUITING	SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.
NCT05044897	PHASE2	ACTIVE_NOT_RECRUITING	A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC
NCT05054439	PHASE2	ACTIVE_NOT_RECRUITING	A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC
NCT05668858	PHASE1/PHASE2	RECRUITING	A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
NCT05949606	PHASE1/PHASE2	RECRUITING	A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT06668961	PHASE2	RECRUITING	A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT05039944	PHASE2	TERMINATED	SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies
NCT04603287	PHASE1	ACTIVE_NOT_RECRUITING	A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

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

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).