Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Public ClinicalTrials.gov record NCT03602079. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03602079
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
- HER2-positive Breast Cancer
- HER2 Gene Mutation
- HER-2 Gene Amplification
- HER2 Positive Gastric Cancer
- Salivary Gland Cancer
- Salivary Gland Tumor
- Salivary Gland Carcinoma
- Salivary Gland Neoplasms
- Lung Cancer
- Colo-rectal Cancer
- Rare Diseases
- Solid Tumor
- Recurrent Gastric Cancer
- Recurrent Colon Cancer
- Recurrent Breast Cancer
- Head and Neck Cancer
- Head and Neck Carcinoma
- Bladder Cancer
- Cervical Cancer
- Liver Cancer
- Bile Duct Cancer
- Urologic Cancer
- Pancreatic Cancer
- Prostate Cancer
- Recurrent Prostate Cancer
- Rectal Cancer
- Recurrent Ovarian Carcinoma
- Recurrent Renal Cell Cancer
- Rectal Cancer Stage II
- Rectal Cancer Stage I
- Rectal Cancer Stage III
- Skin Cancer
- Mouth Cancer
- Lip Cancer Stage I
- Tongue Cancer
- Breast Neoplasm Malignant Primary
- Larynx Cancer
- Tonsil Cancer
- Palate Cancer
- Mucoepidermoid Carcinoma
- Primary Peritoneal Carcinoma
- Mucinous Adenocarcinoma Gastric
- Mucinous Breast Cancer Recurrent
- Cholangiocarcinoma
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 15, 2018
- Primary completion
- Jan 11, 2022
- Completion
- Jan 11, 2022
- Last update posted
- Aug 2, 2023
2018 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Cancer Specialists & Research Institute | Sarasota | Florida | 34232 | — |
| Beth Israel Deaconess Medical Center Cancer Center | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Clinical Research Alliance, Inc. | Lake Success | New York | 11042 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Cancer Institute | Portland | Oregon | 97213 | — |
| Mary Crowley Cancer Research Centers - Medical City | Dallas | Texas | 75230 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| South Texas Accelerated Research Therapeutics, LLC (START) | San Antonio | Texas | 78229 | — |
| Virginia Cancer Specialist | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03602079, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03602079 live on ClinicalTrials.gov.