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NOT YET RECRUITING
NCT07362888
PHASE1

First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

Sponsor: Adcendo ApS

View on ClinicalTrials.gov

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

Interventions

DRUG

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