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First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-03-31
Completion Date
2029-03-14
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
ADCE-B05
Biological: Antibody-drug conjugate (ADC)
Locations (7)
Highlands Oncology Group
Springdale, Arkansas, United States
Yale University
New Haven, Connecticut, United States
University Of Texas MD Anderson Cancer Center
Houston, Texas, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Monash Health
Clayton, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia