Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Bile Duct Cancer
- Bladder Cancer
- Pancreatic Cancer
- Larynx Cancer
- Rectal Cancer Stage II
- Salivary Gland Carcinoma
- Palate Cancer
- Breast Neoplasm Malignant Primary
- Mouth Cancer
- Cervical Cancer
- Liver Cancer
- Salivary Gland Neoplasms
- Primary Peritoneal Carcinoma
- Rectal Cancer Stage I
- Solid Tumor
- Tonsil Cancer
- Recurrent Prostate Cancer
- Skin Cancer
- Salivary Gland Cancer
- Lung Cancer
- Cholangiocarcinoma
- Colo-rectal Cancer
- Rare Diseases
- Recurrent Ovarian Carcinoma
- Prostate Cancer
- Rectal Cancer
- Rectal Cancer (Stage III)
- Salivary Gland Tumor
- Lip Cancer Stage I
- Mucoepidermoid Carcinoma
- Mucinous Adenocarcinoma Gastric
- Head and Neck Carcinoma
- Recurrent Renal Cell Cancer
- HER-2 Gene Amplification
- Recurrent Breast Cancer
- Urologic Cancer
- Recurrent Gastric Cancer
- Tongue Cancer
- Mucinous Breast Cancer Recurrent
- HER2 Positive Breast Cancer
- HER2 Gene Mutation
- HER2 Positive Gastric Cancer
- Recurrent Colon Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 hybrid...
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).
Tracking Information
- NCT #
- NCT03602079
- Collaborators
- Not Provided
- Investigators
- Study Chair: Jordi Rodon Ahnert, MD, PhD MD Anderson
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