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Clinical Trial Summary

Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Patients will receive study drug as a single IV infusion. Cycles will continue until disease progression or unacceptable toxicity.

Clinical Trial Description

This is an open-label, Phase I-II, first-in-human (FIH) study for A166 as monotherapy in HER2-expressing patients who progressed on or did not respond to available standard therapies. Patients enrolled in this Phase III study must have documented HER2 positivity defined as positive on in situ hybridization (ISH) or next-generation sequencing (NGS) or HER2 expression, defined as at least 1+ by validated immunohistochemistry (IHC) test. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease. Patients will receive study drug as a single IV infusion at the prescribed dose level in each treatment cycle. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II). ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Bile Duct Cancer
  • Bile Duct Neoplasms
  • Bladder Cancer
  • Breast Neoplasm Malignant Primary
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Cervical Cancer
  • Cholangiocarcinoma
  • Colo-rectal Cancer
  • Colorectal Neoplasms
  • Cystadenocarcinoma
  • Head and Neck Cancer
  • Head and Neck Carcinoma
  • Head and Neck Neoplasms
  • HER-2 Gene Amplification
  • HER2 Gene Mutation
  • HER2 Positive Gastric Cancer
  • HER2-positive Breast Cancer
  • Laryngeal Neoplasms
  • Larynx Cancer
  • Lip Cancer Stage I
  • Lip Neoplasms
  • Liver Cancer
  • Liver Neoplasms
  • Lung Cancer
  • Mouth Cancer
  • Mouth Neoplasms
  • Mucinous Adenocarcinoma Gastric
  • Mucinous Breast Cancer Recurrent
  • Mucoepidermoid Carcinoma
  • Neoplasms
  • Ovarian Neoplasms
  • Palate Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Primary Peritoneal Carcinoma
  • Prostate Cancer
  • Prostatic Neoplasms
  • Rare Diseases
  • Rectal Cancer
  • Rectal Cancer Stage I
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III
  • Rectal Neoplasms
  • Recurrent Breast Cancer
  • Recurrent Colon Cancer
  • Recurrent Gastric Cancer
  • Recurrent Ovarian Carcinoma
  • Recurrent Prostate Cancer
  • Recurrent Renal Cell Cancer
  • Salivary Gland Cancer
  • Salivary Gland Carcinoma
  • Salivary Gland Neoplasms
  • Salivary Gland Tumor
  • Skin Cancer
  • Skin Neoplasms
  • Solid Tumor
  • Stomach Neoplasms
  • Tongue Cancer
  • Tongue Neoplasms
  • Tonsil Cancer
  • Urinary Bladder Neoplasms
  • Urologic Cancer
  • Urologic Neoplasms
  • Uterine Cervical Neoplasms

NCT number NCT03602079
Study type Interventional
Source Klus Pharma Inc.
Contact Clinical Trials Info at Kluspharma
Phone 609-662-1913
Status Recruiting
Phase Phase 1/Phase 2
Start date July 16, 2018
Completion date May 2021

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