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

Conditions

• HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ZW25 (Zanidatamab) — DRUG
  * Part 1: administered IV at dose levels and schedules determined by the Safety Monitoring Committee (SMC) * Part 2: RD identified in Part 1
• Capecitabine — DRUG
  Administered orally twice daily (PO bid)
• Cisplatin — DRUG
  Administered IV
• Fluorouracil — DRUG
  Administered IV
• Leucovorin — DRUG
  Administered IV
• Oxaliplatin — DRUG
  Administered IV
• Bevacizumab — DRUG
  Administered IV
• Gemcitabine — DRUG
  Administered IV

Study Details

This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).

Key Dates

First listed

Apr 29, 2019

Start date

Aug 29, 2019

Status verified

Sep 2025

Primary completion

Aug 30, 2025

Completion

Aug 30, 2025

Study Design

Enrollment

74 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ZW25 + FP
  ZW25 plus fluorouracil (5-FU) and cisplatin
• Experimental: ZW25 + mFOLFOX6
  ZW25 plus 5-FU, leucovorin, and oxaliplatin
• Experimental: ZW25 + XELOX
  ZW25 plus capecitabine and oxaliplatin
• Experimental: ZW25 + mFOLFOX6 with bevacizumab
  ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
• Experimental: ZW25 + CisGem
  ZW25 plus cisplatin and gemcitabine

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) (Part 1) [ Time Frame: Up to 6 weeks ]

Locations (11)

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