Neoplasms

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All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

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Stomach Neoplasms

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ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:

ZW25 (Zanidatamab)

Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4

Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5

Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6

Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7

Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)

This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).

Part 1 of the study will evaluate increasing doses of ZW25 to find the highest dose of ZW25 that does not cause unacceptable side effects (maximum-tolerated dose or MTD), the lowest safe dose with the highest rate of effectiveness (optimal biological dose or OBD), and/or other recommended dosages (RDs) of ZW25 in up to 7 dose-specific cohorts. Eligible patients include those with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy).

Part 2 of the study will further evaluate the safety, tolerability, and efficacy of ZW25 in patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy) in up to 5 separate disease-specific cohorts.

Part 3 of the study will evaluate the safety, tolerability, and efficacy of ZW25 combined with selected chemotherapy agents, including paclitaxel, capecitabine, vinorelbine, or capecitabine and tucatinib. Patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after at least 1 and no more than 3 prior systemic chemotherapy regimens will be evaluated in this part of the study.

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers

Jazz Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers	NCT02892123	HER2-expressing...	ZW25 (Zanidatam... Paclitaxel Capecitabine Vinorelbine Tucatinib Tucatinib	18 Years -	Jazz Pharmaceuticals
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers	NCT02892123	HER2-expressing...	ZW25 (Zanidatam... Paclitaxel Capecitabine Vinorelbine Tucatinib Tucatinib	18 Years -	Jazz Pharmaceuticals

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