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