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Zaniducla

(Zanidatamab)

Phase 3Monoclonal antibody

Jazz Pharmaceuticals

Zanidatamab is used to treat certain types of stomach cancer and gastroesophageal junction cancer in patients whose tumors have specific genetic characteristics (HER2 positivity). It works by targeting and blocking cancer cells that have too much of a protein called HER2.[1] Zaniducla is currently being investigated across 12 indications[3], with its most advanced program in Phase 3.[1]

Zaniducla is one of 239 biologic programs targeting Biliary Tract Neoplasm. It is currently in Phase 3.

12

Indications

26

Total Trials

23

Active Trials

238

Competitors

Pipeline

Status by Indication[3][1]

Indication

Biliary Tract NeoplasmUnknown

Biliary Tract CancerNot yet recruiting

Breast CancerRecruiting

Gastric CancerNot yet recruiting

Gastroesophageal AdenocarcinomaRecruiting

Biliary Tract Cancer (BTC)Not yet recruiting

Metastatic Breast CancerRecruiting

Biliary CancerRecruiting

Patients With Solid TumorsRecruiting

Colon and Rectal CancerNot yet recruiting

Biliary Tract NeoplasmPreclinical

Unknown

Biliary Tract CancerPhase 3

Not yet recruiting

Breast CancerPhase 3

Recruiting

Gastric CancerPhase 2

Not yet recruiting

Gastroesophageal AdenocarcinomaPhase 2

Recruiting

Biliary Tract Cancer (BTC)Phase 3

Not yet recruiting

Metastatic Breast CancerPreclinical

Recruiting

Biliary CancerPhase 3

Recruiting

Patients With Solid TumorsPhase 2

Recruiting

Colon and Rectal CancerPhase 2

Not yet recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zaniducla

Jazz Pharmaceuticals

Blenoxane

Bristol-Myers Squibb

Voltaren

Zolymbus

Lexiscan

Methylthioninium Chloride

PProvepharm SAS

MS Contin

HHikma Pharmaceuticals LLC

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

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

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Gastroesophageal Adenocarcinoma

NCT06043427

Phase 3Active, not recruiting

Gastric Neoplasms

NCT05152147

Q4 2027

Phase 2Recruiting

Breast Cancer

NCT06695845

Q2 2028

Phase 3Recruiting

Biliary Cancer

NCT05615818

Q4 2028

Phase 2Recruiting

Gastroesophageal Adenocarcinoma

NCT07290985

Phase 2Not yet recruiting

Gastric Cancer

NCT07685704

Clinical

Trials by Indication[1]

Breast Cancer5 trials

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT01042379·5,000 enrolled

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

Recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT06435429·550 enrolled

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

Recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT06695845·200 enrolled

Show 2 more trials

Phase 1b/2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-HER2 Bispecific Antibody ZW25 in Combination With Chemotherapy With/Without Tislelizumab in Patients With Advanced HER2-positive Breast Cancer or Gastric/Gastroesophageal Junction Adenocarcinoma

Completed· BeiGene logo

BeiGene·Preclinical·NCT04276493·71 enrolled

A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05035836·20 enrolled

Biliary Tract Cancer3 trials

An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer

No longer available· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals··NCT04578444

An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

Recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT06282575·286 enrolled

Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract Tumors: A Multicenter, Single-arm, Phase II Clinical Study

Not yet recruiting·AAnhui Provincial Hospital·Phase 2·NCT07841873·15 enrolled

Gastroesophageal Adenocarcinoma3 trials

AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)

Recruiting·AAmerican Association for Cancer Research·Phase 2·NCT07290985·242 enrolled

A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT06043427·168 enrolled

- ZANGEA - Phase II Study of Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT07176312·80 enrolled

HER2 Positive2 trials

Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC

Recruiting·FFujian Medical University Union Hospital·Phase 2·NCT07296705·25 enrolled

Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)

Not yet recruiting·TTao Zhang·Phase 2·NCT07243938·70 enrolled

HER2-positive Breast Cancer2 trials

A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT07102381·125 enrolled

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/II Platform Trial

Recruiting·QQuantumLeap Healthcare Collaborative·Preclinical·NCT05868226·280 enrolled

11 more indications

Patients With Solid Tumors1 trial

Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.

Recruiting·UUNICANCER·Phase 2·NCT07192068·105 enrolled

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 enrolled

Advanced Malignancies1 trial

Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

Enrolling by invitation·BBeOne Medicines·Phase 3·NCT04164199·430 enrolled

Colon and Rectal Cancer1 trial

Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment

Not yet recruiting·EEmory University·Phase 2·NCT07405476·38 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase 1a/1b Of Zanidatamab In Combination With Zongertinib In HER2-Mutated Non-Small Cell Lung Cancer (NSCLC)

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07899801·24 enrolled

Metastatic Breast Cancer1 trial

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Preclinical·NCT06324357·910 enrolled

Esophageal Cancer1 trial

Real-World Utilization, Treatment Patterns, Tolerability, and Effectiveness of Zanidatamab in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma in the United States

Not yet recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals··NCT07780968·300 enrolled

Gastric Neoplasms1 trial

A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

Active, not recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT05152147·920 enrolled

Biliary Tract Cancer (BTC)1 trial

Investigating Precision Medicine in the Adjuvant Setting: a Phase 3 Clinical Trial in Biliary Tract Cancer

Not yet recruiting·UUNICANCER·Phase 3·NCT07745296·990 enrolled

Gastric Cancer1 trial

A Phase II Open-Label Study Evaluating the Efficacy and Safety of Zanidatamab Combined With Chemotherapy as Neoadjuvant/Conversion Therapy in Patients With HER2-Positive (IHC 3+ or IHC 2+) Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Not yet recruiting·ZZhifeng Zhao, PhD·Phase 2·NCT07685704·46 enrolled

Cancers1 trial

A Phase 1b/2, 2-part Open-label Study to Assess the Safety and Antitumor Activity of Zanidatamab in Combination With ALX148 in Advanced HER2-expressing Cancer

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Preclinical·NCT05027139·52 enrolled

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Zanidatamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zanidatamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zanidatamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Receptor Protein-Tyrosine Kinase Erbb-2 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Jazz Pharmaceuticals

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