Active trials, both recruiting and not recruiting, testing the HER2 pathway
NCT | Phase | Status | Tumors | Line of treatment | Target | Experimental treatment | Standard treatment | Primary endpoints | Sponsor |
---|---|---|---|---|---|---|---|---|---|
NCT03613168 | 2 | Completed | CCA | 1 L | HER2 | Cis + Gem + trastuzumab | N.A. | ORR, AEs | No-profit |
NCT04430738 | 1/2 | Recruiting | CCA | ≥ 1 L (not prior oxaliplatin) | HER2 | FOLFOX or CAPOX + tucatinib + trastuzumab | N.A. | AEs | Profit |
NCT03602079 | 1/2 | Recruiting | CCA | NTA | HER2 | A166 (ADC targeting HER2) | N.A. | MTD, ORR | Profit |
NCT00004074 | 1 | Completed | eCCA and GBC | NTA | HER2 | IL12 + trastuzumab | N.A. | MTD | No-profit |
NCT04660929 | 1 | Recruiting | CCA | NTA | HER2 | CT-0508 (anti-HER2 CAR macrophages) | N.A. | Safety, tolerability and feasibility | Profit |
NCT04466891 | 2 | Recruiting | CCA | ≥ 2 L | HER2 | Zanidatamab | N.A. | ORR | Profit |
NCT04579380 | 2 | Recruiting | CCA | ≥ 2 L | HER2 | Tucatinib + trastuzumab | N.A. | ORR | Profit |
NCT03821233 | 1 | Recruiting | CCA | NTA | HER2 | ZW49 | N.A. | AEs, safety | Profit |
NCT00005842 | 1 | Completed | CCA | ≥ 1 L | Trastuzumab + tipirfanib | N.A. | MTD, antitumor activity | No-profit |
We also reported three trials defined as “completed” on www.clinicaltrials.gov, whose results have never been published. CAPOX: capecitabine + oxaliplatin; CAR: chimeric antigen receptor; ADC: antibody-drug conjugate
MDM, DM, ES contributed conception and design of the review; AC, TG, FDV organized the database; GA, CP, CZ wrote the first draft of the manuscript. All authors contributed to manuscript revision, read and approved the submitted version.
The authors declare the following financial interests/personal relationships that may be considered as potential competing interests: Massimo Di Maio received honoraria and had roles as consultant or advisor for AstraZeneca, Pfizer, Novartis, Roche, Takeda, Eisai, Janssen, Astellas; received institutional research grant by Tesaro e GlaxoSmithKline, outside the submitted work. All remaining authors declared no conflicts of interest.
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© The Author(s) 2021.