A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Titre officiel

Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)

Sommaire:

Étude ouverte de phase II multicentrique, mondiale, en deux parties et de première intention, portant sur l’innocuité, la tolérabilité et l’activité antitumorale du ZW25 administré en concomitance avec une chimiothérapie d’association au choix du médecin pour le traitement des adénocarcinomes gastro-œsophagiens (AGE) exprimant HER2. Les patients admissibles comprennent les patients atteints d’un AGE HER2-positif, non résécable, localement avancé, récurrent ou métastatique.

Description de l'essai

Primary Outcome:

• Incidence of dose-limiting toxicities (DLTs) (Part 1)
• Incidence of adverse events (Part 1)
• Incidence of lab abnormalities (Part 1)
• Objective response rate (ORR) (Part 2)

Secondary Outcome:

• Objective response rate (ORR) (Part 1)
• Disease control rate (Parts 1 and 2)
• Duration of response (Parts 1 and 2)
• Clinical benefit rate (Parts 1 and 2)
• Progression-free survival (Parts 1 and 2)
• Overall survival (Parts 1 and 2)
• Incidence of anti-drug antibodies (ADAs) (Parts 1 and 2)
• End of infusion concentration of ZW25 (Parts 1 and 2)
• Maximum serum concentration of ZW25 (Parts 1 and 2)
• Trough concentration of ZW25 (Parts 1 and 2)
• Incidence of adverse events (Part 2)
• Incidence of lab abnormalities (Part 2)

Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy (XELOX, FP, or mFOLFOX6 for GEA; mFOLFOX6 with or without bevacizumab for CRC; and CisGem for BTC) and will confirm the recommended dosage (RD) of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens. Then, Part 2 of the study will evaluate the anti-tumour activity of ZW25 plus combination chemotherapy in HER2-expressing GEA, BTC, and CRC.

Voir cet essai sur ClinicalTrials.gov