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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States
Beth Israel Deaconess Medical Center Cancer Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Clinical Research Alliance, Inc.
Lake Success, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Cancer Institute
Portland, Oregon, United States
Mary Crowley Cancer Research Centers - Medical City
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Virginia Cancer Specialist
Fairfax, Virginia, United States
Phase I: Maximum Tolerated Dose
Number of patients with dose limiting toxicities
Time frame: Minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Phase I: Number of patients with Dose Limiting Toxicities
Time frame: Minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Phase I: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Time frame: Every 3 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Phase I: Number of participants who developed measurable anti-drug antibodies
Time frame: Minimum of 21 days from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Phase I Maximum observed serum or plasma concentration (Cmax).
Time frame: 84 Days from date of first dose
Phase I Clearance (CL).
Time frame: 84 Days from date of first dose
Phase I Area under the serum or plasma concentration time curve from 0 to infinity (AUC[0-∞]).
Time frame: 84 Days from date of first dose
Phase I Terminal phase elimination half life (t½).
Time frame: 84 Days from date of first dose
Phase I Volume of distribution at terminal phase (Vz).
Time frame: 84 Days from date of first dose
Phase I Volume of distribution at steady state (Vss).
Time frame: 84 Days from date of first dose
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