Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (NCT02892123) | Clinical Trial Compass
CompletedPhase 1
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers
United States279 participantsStarted 2016-09-30
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. HER2-expressing cancer as follows:
✓. ≥ 18 years of age
✓. ECOG performance status of 0 or 1
✓. Life expectancy of at least 3 months per the investigator's assessment.
✓. Adequate organ function
✓. Adequate cardiac left ventricular function, as defined by a LVEF \>/= institutional standard of normal
✓. For Part 1 Cohorts 1 - 3: evaluable disease (target or non-target lesions) per RECIST version 1.1. For Part 1 Cohorts 4 - 7, and Parts 2 and 3: measurable disease (target lesions) per RECIST version 1.1
✓. Able to provide tumor sample (fresh or archived)
Exclusion criteria
✕. Experimental therapies within 4 weeks before first ZW25 dosing
✕. Treatment with other cancer therapy not otherwise specified within 4 weeks before ZW25 dosing
✕. Anthracyclines within 90 days before first ZW25 dosing or lifetime load exceeding 300 mg/m² adriamycin or equivalent
✕. Trastuzumab, pertuzumab, lapatinib, or T-DM1 within 3 weeks before first ZW25 dosing
✕. Patients in Part 3 TG4 must not have received prior taxanes
What they're measuring
1
The proportion of patients who experience dose-limiting toxicities (DLTs) (Part 1)
Timeframe: Up to 8 months
2
The proportion patients who experience laboratory abnormalities and/or adverse events as defined by CTCAE v4.03 that are related to treatment (Parts 2 and 3)
Timeframe: Throughout the duration of the study; up to 2 years
✕. Patients in Part 3 TG5 must not have received prior capecitabine for metastatic disease or received any prior fam-trastuzumab deruxtecan-nxki (DS-8201a)
✕. With the exception of Part 3 TGs 7 and 8, untreated brain metastases (patients with treated brain mets who are off steroids and are stable for at least 1 month at the time of screening are eligible)