Also known as: Ziihera, ZIIHERA
Zanidatamab-hrii is marketed as Ziihera, a bispecific HER2-directed antibody approved under accelerated approval for previously treated unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. It represents a HER2-targeted biologic option in advanced BTC after prior therapy.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07494448 |
Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07405476 |
Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment |
RECRUITING | PHASE2 |
| NCT07296705 |
Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC |
RECRUITING | PHASE2 |
| NCT07290985 |
AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas |
NOT_YET_RECRUITING | PHASE2 |
| NCT07243938 |
Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07192068 |
Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. |
RECRUITING | PHASE2 |
| NCT07176312 |
Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients |
RECRUITING | PHASE2 |
| NCT07102381 |
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer |
RECRUITING | PHASE2 |
| NCT06695845 |
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors |
RECRUITING | PHASE2 |
| NCT06435429 |
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 | PHASE3 |
