Zanidatamab

Summary

Zanidatamab (CHEMBL4650256) is an approved antibody (ATC L01FD07); indicated across 9 conditions including neoplasm and biliary tract neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FD07
• Indications: 9 conditions
• Clinical trials: 28

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4650256
Name	Zanidatamab
Type	Antibody
Max phase	4
ATC	L01FD07

Also known as: Zanidatamab, Zanidatamab-hrii, Ziihera, ZW-25, ZW25, ZANIDATAMAB

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

9 indications (5 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
neoplasm	4	MONDO:0005070	EFO:0000616
biliary tract neoplasm	4	MONDO:0005304	EFO:0003891
breast neoplasm	3	MONDO:0021100	MONDO:0007254
gastric neoplasm	2	MONDO:0021085	MONDO:0001056
angiosarcoma	2	MONDO:0016982	EFO:0003968

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

Clinical trials

Total trials: 28.

Phase distribution

Phase	Trials
PHASE2	16
PHASE3	5
PHASE1/PHASE2	4
PHASE1	2
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04164199	PHASE3	ACTIVE_NOT_RECRUITING	Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
NCT05152147	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
NCT05615818	PHASE3	RECRUITING	Personalized Medicine for Advanced Biliary Cancer Patients
NCT06282575	PHASE3	RECRUITING	Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
NCT06435429	PHASE3	RECRUITING	A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician’s Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
NCT01042379	PHASE2	RECRUITING	I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT05035836	PHASE2	RECRUITING	A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)
NCT06043427	PHASE2	RECRUITING	Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
NCT06324357	PHASE1/PHASE2	RECRUITING	Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
NCT06695845	PHASE2	RECRUITING	A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
NCT07102381	PHASE2	RECRUITING	A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
NCT07176312	PHASE2	RECRUITING	Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients
NCT07192068	PHASE2	RECRUITING	Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
NCT07243938	PHASE2	NOT_YET_RECRUITING	Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)
NCT07290985	PHASE2	NOT_YET_RECRUITING	AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
NCT07296705	PHASE2	RECRUITING	Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC
NCT07405476	PHASE2	RECRUITING	Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment
NCT07494448	PHASE1/PHASE2	NOT_YET_RECRUITING	Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
NCT03929666	PHASE2	COMPLETED	A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
NCT04224272	PHASE2	COMPLETED	A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer
NCT04276493	PHASE1/PHASE2	COMPLETED	Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
NCT04466891	PHASE2	COMPLETED	A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
NCT04513665	PHASE2	COMPLETED	ZW25 in Women With Endometrial Cancers
NCT05027139	PHASE1/PHASE2	COMPLETED	A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer
NCT05270889	PHASE2	UNKNOWN	Study to Evaluate the Safety and Efficacy of Tislelizumab in Combination With Zanidatamab as a 2nd Line in HER2-Positive Advanced Gastric Cancer in K-Umbrella Trial
NCT05868226	PHASE1	RECRUITING	PRE-I-SPY Phase I/Ib Oncology Platform Program
NCT02892123	PHASE1	COMPLETED	Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers
NCT04578444	Not specified	NO_LONGER_AVAILABLE	An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer

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).