Clinical Trials Directory

Trials / Completed

CompletedNCT03602079

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Klus Pharma Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
DRUGA166A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.

Timeline

Start date
2018-07-16
Primary completion
2022-01-12
Completion
2022-01-12
First posted
2018-07-26
Last updated
2023-08-03

Locations

10 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03602079. Inclusion in this directory is not an endorsement.