NCT07362888

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Adcendo ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Solid Tumors (Phase 1)

Interventions

Type	Name	Description
DRUG	ADCE-B05	Biological: Antibody-drug conjugate (ADC)

Timeline

• Start date: 2026-03-17
• Primary completion: 2026-12-31
• Completion: 2029-03-14
• First posted: 2026-01-23
• Last updated: 2026-04-15

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study