Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZW25 · 4 trials · 4 indications
Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions.
Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant, or any combination of ZW25 and 1 or more of these drugs; and 2) meet the criteria as specified in the protocol.
A treatment-emergent adverse event occurs after the start of study treatment and is defined as any unfavorable or unintended symptom, sign, or disease (including abnormal lab) temporally associated with the use of treatment that may or may not be considered related to treatment. TEAEs were coded using MedDRA v24.0.
The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days).
Number of participants who experienced a DLT. DLTs include adverse events considered to be related to study treatment, including the evaluated dose level of ZW25, any component or combination of the components of a chemotherapy regimen, or the combination of ZW25 plus a chemotherapy regimen.
Number of participants who experienced an adverse event
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
| Arm | Type | Description |
|---|---|---|
| ZW25 (Zanidatamab) Monotherapy | EXPERIMENTAL | - |
| ZW25 (zanidatamab) + palbociclib + fulvestrant | EXPERIMENTAL | ZW25 (zanidatamab) plus palbociclib, fulvestrant |
| ZW25 + FP | EXPERIMENTAL | ZW25 plus fluorouracil (5-FU) and cisplatin |
| ZW25 + mFOLFOX6 | EXPERIMENTAL | ZW25 plus 5-FU, leucovorin, and oxaliplatin |
| ZW25 + XELOX | EXPERIMENTAL | ZW25 plus capecitabine and oxaliplatin |
| ZW25 + mFOLFOX6 with bevacizumab | EXPERIMENTAL | ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab |
| ZW25 + CisGem | EXPERIMENTAL | ZW25 plus cisplatin and gemcitabine |
| ZW25 (Zanidatamab) Monotherapy and ZW25 Combination Therapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZW25 (Zanidatamab) | DRUG | Administered intravenously |
| Palbociclib | DRUG | Administered orally |
| Fulvestrant | DRUG | Administered as an intramuscular injection |
| Capecitabine | DRUG | Administered orally twice daily (PO bid) |
| Cisplatin | DRUG | Administered IV |
| Fluorouracil | DRUG | Administered IV |
| Leucovorin | DRUG | Administered IV |
| Oxaliplatin | DRUG | Administered IV |
| Bevacizumab | DRUG | Administered IV |
| Gemcitabine | DRUG | Administered IV |
| Paclitaxel | DRUG | Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4 |
| Vinorelbine | DRUG | Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6 |
| Tucatinib | DRUG | Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7 |
Inclusion Criteria: * Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC. * Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies. * Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for...
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ZW25, also known as zanidatamab, is an investigational oncology therapy being studied for HER2-expressing cancers. Its clinical development has focused on HER2-amplified biliary tract cancers, HER2+/HR+ breast cancer, and HER2-expressing gastrointestinal cancers, including gastroesophageal adenocarcinoma, biliary tract cancer, and colorectal cancer.
ZW25 targets HER2, a protein commonly expressed in certain cancers. It is being developed as a treatment for HER2-expressing tumors, including HER2-amplified biliary tract cancers and HER2+/HR+ breast cancer.
ZW25 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company listed on the stock exchange under the ticker JAZZ.
ZW25 has completed Phase 2 clinical trials. It remains an investigational drug and is not approved by regulatory authorities. The completed trials include studies in HER2-expressing gastrointestinal cancers, HER2+/HR+ breast cancer, and HER2-amplified biliary tract cancers.
ZW25 has been studied in several completed clinical trials, including NCT02892123, a Phase 1 trial in HER2-expressing cancers; NCT03929666, a Phase 2 trial in HER2-expressing gastrointestinal cancers; NCT04224272, a Phase 2 trial in HER2+/HR+ breast cancer; and NCT04466891, a Phase 2 trial in HER2-amplified biliary tract cancers.
Yes, ZW25 is also known as zanidatamab. Both names refer to the same investigational drug being developed by Jazz Pharmaceuticals for HER2-expressing cancers.