Clinical Trials Logo
  1. Home
  2. Prostate Cancer
  3. NCT03602079

Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

Prostate Cancer Clinical Trial

Official title:
A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies

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, 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
  • Cystadenocarcinoma
  • Head and Neck Cancer
  • Head and Neck Carcinoma
  • 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
  • Lung Cancer
  • Mouth Cancer
  • Mouth Neoplasms
  • Mucinous Adenocarcinoma Gastric
  • Mucinous Breast Cancer Recurrent
  • Mucoepidermoid Carcinoma
  • Neoplasms
  • Palate Cancer
  • Pancreatic Cancer
  • 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
  • Recurrence
  • 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
  • Solid Tumor
  • Stomach Neoplasms
  • Tongue Cancer
  • Tongue Neoplasms
  • Tonsil Cancer
  • Urologic Cancer
  • Urologic Neoplasms
Clinical Trial Details
NCT number NCT03602079
Study type Interventional
Source Klus Pharma Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 16, 2018
Completion date January 12, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A