drugset
drugset / Trial / NCT03602079

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

NCT03602079 ↗

Phase 1/2 Completed 49 enrolled Klus Pharma Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2018-07-16
Primary completion
2022-01-12
Completion
2022-01-12

Drugs

EvaluationDrugModalityDoseRoute
Subject TRASTUZUMAB BOTIDOTIN Unknown 0.3 mg/kg Intravenous
Subject TRASTUZUMAB BOTIDOTIN Unknown 0.6 mg/kg Intravenous
Subject TRASTUZUMAB BOTIDOTIN Unknown 1.2 mg/kg Intravenous
Subject TRASTUZUMAB BOTIDOTIN Unknown 2.4 mg/kg Intravenous
Subject TRASTUZUMAB BOTIDOTIN Unknown 3.6 mg/kg Intravenous
Subject TRASTUZUMAB BOTIDOTIN Unknown 4.8 mg/kg Intravenous

Indications

Gaucher ichthyosis restrictive dermopathy HER2 positive breast carcinoma breast mucinous carcinoma cervical cancer cholangiocarcinoma larynx cancer lip cancer lung cancer malignant pancreatic neoplasm mucinous gastric adenocarcinoma mucoepidermoid carcinoma ovarian carcinoma palatal neoplasm primary peritoneal carcinoma prostate carcinoma rectal cancer renal cell carcinoma salivary gland carcinoma skin cancer tongue cancer tonsil cancer urinary bladder cancer