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

NCT03602079 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-08-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

A166

A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.

Sponsors & Collaborators

  • Klus Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Jordi Rodon Ahnert, MD, PhD · MD Anderson

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2022-01-12
Completion
2022-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602079 on ClinicalTrials.gov