This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
165
PHN-012 is an ADC
PHN-012-001 Site
Incidence of dose limiting toxicities (Phase 1a)
Time frame: 12 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
Time frame: 12 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
Time frame: 24 months
Overall response rate (ORR) (Phase 1b)
Time frame: 12 months
Best overall response (BOR) (Phase 1a and 1b)
Time frame: 24 months
Disease control rate (DCR) (Phase 1a and 1b)
Time frame: 24 months
Progression free survival (PFS) (Phase 1a and 1b)
Time frame: 24 months
Time to response (TTR) (Phase 1a and 1b)
Time frame: 24 months
Overall survival (OS) (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)
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Los Angeles, California, United States
PHN-012-001 Site
San Diego, California, United States
RECRUITINGPHN-012-001 Site
Washington D.C., District of Columbia, United States
RECRUITINGPHN-012-001 Site
Boston, Massachusetts, United States
RECRUITINGPHN-012-001 Site
St Louis, Missouri, United States
RECRUITINGPHN-012-001 Site
Durham, North Carolina, United States
RECRUITINGPHN-012-001 Site
Portland, Oregon, United States
RECRUITINGPHN-012-001 Site
Nashville, Tennessee, United States
RECRUITINGPHN-012-001 Site
Houston, Texas, United States
RECRUITINGPHN-012-001 Site
San Antonio, Texas, United States
RECRUITING...and 16 more locations
Time frame: 24 months
Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)
Time frame: 24 months
Concentration of anti-drug antibodies (Phase 1a and 1b)
Time frame: 24 months
Type, incidence and severity of AEs and SAEs (Phase 1b)
Time frame: 12 months