This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
PHN-010 is an ADC
AdventHealth
Orlando, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Incidence of dose limiting toxicities (Phase 1a)
Time frame: 18 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
Time frame: 18 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
Time frame: 18 months
Overall response rate (ORR) (Phase 1b)
Time frame: 36 months
Best overall response (BOR) (Phase 1a and 1b)
Time frame: 36 months
Disease control rate (DCR) (Phase 1a and 1b)
Time frame: 36 months
Progression free survival (PFS) (Phase 1a and 1b)
Time frame: 36 months
Time to response (TTR) (Phase 1a and 1b)
Time frame: 36 months
Overall survival (OS) (Phase 1a and 1b)
Time frame: 36 months
Cancer antigen 125 (CA-125) response (Phase 1a and 1b)
Time frame: 36 months
Time to CA-125 response (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)
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MD Anderson Cancer Center
Houston, Texas, United States
NEXT - San Antonio
San Antonio, Texas, United States
NEXT - Virginia
Fairfax, Virginia, United States
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, United States
Time frame: 36 months
Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)
Time frame: 36 months
Concentration of anti-drug antibodies (Phase 1a and 1b)
Time frame: 36 months
Type, incidence and severity of AEs and SAEs (Phase 1b)
Time frame: 18 months