A First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors
Adcendo ApS
Summary
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.
Description
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugADCE-B05
Biological: Antibody-drug conjugate (ADC)
Locations (7)
- Highlands Oncology GroupSpringdale, Arkansas
- Yale UniversityNew Haven, Connecticut
- University Of Texas MD Anderson Cancer CenterHouston, Texas
- Scientia Clinical ResearchRandwick, New South Wales
- Southern Oncology Clinical Research UnitBedford Park, South Australia
- Monash HealthClayton, South Australia