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Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer — GEN602  

Breast Cancer Clinical Trial

Official title:
A Phase I/Ib, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination With Capecitabine, Given Orally on a Daily Schedule in Patients With Advanced Solid Tumors or Lymphoma

Clinical Trial Summary

This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients with Advanced Solid Tumors or Lymphoma

Clinical Trial Description

This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to patients with advanced solid tumors or lymphoma, which have progressed after receiving standard/approved therapy or where there is no approved therapy. This study will determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of GZ17-6.02 monotherapy and in combination with standard-of-care oncology treatments and to establish the dose of GZ17-6.02 recommended for future monotherapy and combination therapies phase II oncology clinical studies. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Cancer
  • Basal Cell Carcinoma
  • Breast Cancer
  • Breast Neoplasms
  • Cancer of Stomach
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Colo-rectal Cancer
  • Cutaneous Squamous Cell Carcinoma
  • Cutaneous T Cell Lymphoma
  • Cutaneous T-cell Lymphoma
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Pancreatic Cancer
  • Prostate Cancer Metastatic
  • Sarcoma
  • Solid Carcinoma
  • Solid Carcinoma of Stomach
  • Solid Tumor
  • Squamous Cell Carcinoma of Head and Neck
  • Stomach Neoplasms
Clinical Trial Details
NCT number NCT03775525
Study type Interventional
Source Genzada Pharmaceuticals USA, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 1, 2019
Completion date December 2023
View Details
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