PO.CTP01.03 · 进行中的临床试验
DiscovHER PAN-206: Phase 2 tumor-agnostic study of zanidatamab in patients with previously treated human epidermal growth factor receptor 2-overexpressing solid tumors
该海报暂无可访问的完整资料
AACR 官方页面 ↗
作者与单位
摘要 Abstract
Background: Tissue-agnostic HER2 targeting is a rational, precision-oncology approach for treating HER2-expressing tumors due to the protein's expression across multiple tumor types and potential oncogenic role. Zanidatamab, a dual HER2-targeted bispecific antibody, is approved as monotherapy by the US Food and Drug Administration for adults with previously treated, unresectable or metastatic HER2-positive immunohistochemistry (IHC) 3+ biliary tract cancer (BTC) based on the phase 2 HERIZON-BTC-01 trial. In 62 patients with previously treated BTC, the confirmed objective response rate (cORR) was 52% and the median duration of response (DOR) was 14.9 months. Zanidatamab has also shown encouraging antitumor activity with a manageable safety profile in a phase 1 study of heavily pretreated patients with various HER2-expressing solid tumors.
Methods: DiscovHER PAN-206 (NCT06695845) is an open-label, single-arm, multicenter study of zanidatamab monotherapy in adults with centrally assessed HER2 IHC 3+, locally advanced, unresectable or metastatic solid tumors (except BTC) who received ≥1 prior anticancer therapy and have no available treatment options with confirmed benefit. Eligible patients must have an Eastern Cooperative Oncology Group performance status of 0 or 1 and measurable disease by independent central review (ICR; per Response Evaluation Criteria in Solid Tumors version 1.1). Patients will be enrolled into 3 cohorts: cohort 1 (any solid tumor except breast cancer [BC] and gastroesophageal adenocarcinoma [GEA]), cohort 2 (BC), and cohort 3 (GEA). No prior HER2-targeted therapy is allowed for cohort 1; prior treatment with trastuzumab deruxtecan is required for cohorts 2 and 3. Zanidatamab will be administered intravenously once every 3 weeks at 1800 mg (patients <70 kg) or 2400 mg (patients ≥70 kg), until disease progression or unacceptable toxicity. The primary endpoint is cORR per ICR. Secondary endpoints include overall survival and frequency of adverse events; cORR per investigator; and DOR, time to response, disease control rate, and progression-free survival per ICR and investigator assessment. Exploratory endpoints include patient-reported outcomes. This trial is open for enrollment. Originally presented at the 2025 European Society for Medical Oncology Annual Meeting.
利益披露 Disclosure
V. Subbiah,
Abbvie ), Other, consulting/advisory role.
Bayer HealthCare Pharmaceuticals, Inc ), Other, consulting/advisory role.
F. Hoffmann-La Roche ), Other, consulting/advisory role.
Illumina Other, consulting/advisory role; other professional activities.
Incyte Corporation ), Travel, Other, consulting/advisory role.
Jazz Pharmaceuticals, Inc. Other, consulting/advisory role; support for other professional activities.
LabCorp Other, consulting/advisory role.
Regeneron Pharmaceuticals, Inc Other, consulting/advisory role.
Relay Therapeutics ), Other, consulting/advisory role.
Aadi Biosciences Other, Support for other professional activities.
Clinical Care Communications Other, Support for other professional activities.
Med Learning Group Other, Support for other professional activities.
Medscape Other, Support for other professional activities.
Phenon Therapeutics Other, Support for other professional activities.
AgenSys, Alfa-Sigma, Altulum, Amgen, Berghealth, Blueprint Medicines, Boston Biomedical, Boston Pharmaceuticals, Celgene Corporation, Dragonfly Therapeutics, Exelixis Inc ).
FUJIFILM Medical Systems USA, Inc; Genentech USA, Inc; GlaxoSmithKline; Idera Pharma; Inhibrx; LOXO Oncology, LLC; MedImmune; Multivir; Nanocarrier; NCCN; NCI; Novartis Pharma; OncLive; Oncusp; PERS ).
Pfizer; PharmaMar; Takeda Oncology ).
ASCO; ESMO Travel.
Helsinn Healthcare SA Travel.
V. Makker,
ArQule; Clovis; Duality; Eisai; Faeth Therapeutics; GlaxoSmithKline; IBM Watson; ITeos Therapeutics; Kartos Therapeutics; Karyopharm; Lilly; Merck; Novartis; and Takeda Other, consulting or advisory role.
AstraZeneca; Bayer; Bristol Myers Squibb; Clovis; Duality; Eisai; Faeth Therapeutics; Karyopharm Therapeutics; Lilly; Merck; Takeda; and Zymeworks ).
Eisai; Karyopharm Therapeutics; and Merck Travel, accommodations and expenses.
IBM Other.
D. Oh,
Arcus Biosciences; ASLAN Pharmaceuticals; AstraZeneca; Bayer; Basilea; BeiGene; Celgene; Genentech/Roche; Halozyme; IQVIA; Merck Serono; MSD Oncology; Novartis; and Taiho Pharmaceutical; Other, consulting or advisory role.
Turning Point Therapeutics; Yuhan; and Zymeworks Other, consulting or advisory role.
Array BioPharma; AstraZeneca; BeiGene; Eli Lilly; Handok; MSD; Novartis; and SERVIER ).
E. Gardener,
Jazz Pharmaceuticals Employment, Stock, Stock Option.
E. Gartner,
Jazz Pharmaceuticals Employment.
Jazz Pharmaceuticals; and Zymeworks Stock, Stock Option.
F. Meric-Bernstam,
MD Anderson Cancer Center Employment.
Apeiron Biologics; AstraZeneca; Biovica; Black Diamond Therapeutics; Calibr; EcoR1 Capital; Eisai; F. Hoffmann-La Roche; Infinity Pharmaceuticals; Karyopharm Therapeutics; LegoChem Biosciences; Other, consulting or advisory role.
Lengo Therapeutics; LOXO-Oncology; Menarini Group; OnCusp Therapeutics; PACT Pharmaceuticals; Seattle Genetics; Tallac Therapeutics; Theratechnologies; and Zymeworks Other, consulting or advisory role.
AbbVie; Aileron Therapeutics; AstraZeneca; Bayer; Boehringer Ingelheim; Calithera Biosciences; CytomX Therapeutics; Curis; Daiichi-Sankyo; Debiopharm Group; eFFECTOR Therapeutics; Genentech; ).
GlaxoSmithKline; Guardant Health; Jounce Therapeutics; Klus Pharma; Novartis; Pfizer; PUMA Biotechnology; Seattle Genetics; Taiho Pharmaceutical; Taiho Pharmaceutical Co; Takeda; and Zymeworks ).
the Cholangiocarcinoma Foundation; the European Organisation for Research and Treatment of Cancer (EORTC); and the European Society for Medical Oncology (ESMO) Travel, accommodations and expenses.