Adcendo ApS
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of solid tumor * Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies * Radiologically or clinically determined progressive disease during or after most recent line of therapy * Measurable disease per RECIST 1.1 * ECOG performance status of 0 or 1 * Adequate hematological and biochemical parameters * A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of…
Biological: Antibody-drug conjugate (ADC)