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Clinical Trial 19883

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT03929666

Phase: Phase II
Prinicipal Investigator: Rutika Mehta

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Overview

Study Title

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)

Summary

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 physician's choice of combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA). Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA.

Objective

Objectives: To characterize the safety and tolerability of ZW25 when administered with combination chemotherapy in subjects receiving first-line treatment for human epidermal growth factor receptor 2 (HER2)- expressing GEA, BTC, or CRC (physician fs choice of XELOX, FP, mFOLFOX6 for subjects with GEA CisGem for subjects with BTC; and mFOLFOX6 with or without bevacizumab for subjects with CRC) To establish the recommended dose (RD) of ZW25 when administered with combination chemotherapy Secondary: - To evaluate anti-tumor activity of ZW25 when administered with physician's choice of combination chemotherapy in patients receiving first-line treatment for HER2-expressing GEA, BTC, or CRC - To characterize the immunogenicity of ZW25 when administered in combination with physician's choice of first-line combination chemotherapy - To evaluate the PK of ZW25 when administered in combination with physician's choice of first-line combination chemotherapy

Treatments

Therapies

Medications

5-fluorouracil (); Avastin (Bevacizumab); Bevacizumab (); Gemzar (gemcitabine); Oxaliplatin (); Xeloda (capecitabine); ZW25 (); capecitabine (); cisplatin (); eloxatin (Oxaliplatin); gemcitabine (); leucovorin ()

Inclusion Criteria

  • Disease diagnosis:
  • Part 1: Unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA (IHC 3+ or 2+ with or without gene amplification based upon local assessment or central assessment)
  • Part 2: Unresectable, locally advanced, recurrent or metastatic HER2-high GEA (IHC 3+, or IHC 2+ and FISH+ by central review)
  • Tumor measurements as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1:
  • Part 1: Measurable or non-measurable disease
  • Part 2: Measurable disease
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Adequate organ function
  • Adequate cardiac left ventricular function, as defined by a LVEF >/= institutional standard of normal

  • Exclusion Criteria

  • Prior treatment with a HER2-targeted agent
  • Treatment for GEA with prior anti-cancer therapy (including investigational products) except prior adjuvant/neoadjuvant therapy, which must be completed at least 6 months prior to first study treatment dosing. Palliative radiotherapy is allowed if completed at least 2 weeks prior to first study treatment dosing.
  • Untreated known brain metastases (patients with treated brain metastases who are off steroids, off anti-seizure medications, and stable for at least 1 month at the time of screening are eligible)
  • Having clinically significant cardiac disease or known myocardial infarction or unstable angina (within 6 months before first study treatment dosing)
  • QTc Fridericia (QTcF) > 470 ms for females and > 450 ms for males
  • Peripheral neuropathy > Grade 1 per NCI-CTCAE v5.0
  • Clinically significant interstitial lung disease
  • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Active hepatitis B or hepatitis C infection or other known chronic liver disease or infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2 (Exception: patients with well controlled HIV [e.g., CD4 > 350/mm3 and undetectable viral load] are eligible.)

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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