NCT03700294

Safety, Tolerability, Pharmacokinetics, and Antitumor Study of ADCT-601 to Treat Advanced Solid Tumors

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-601 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: ADC Therapeutics S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety, tolerance, pharmacokinetics (PK), and antitumor activity of ADCT-601 in patients with advanced solid tumors.

Detailed description

This is a Phase 1 open-label, multicenter single-arm study with a dose-escalation phase (Part 1) followed by a dose-expansion phase (Part 2). The study will enroll approximately 75 patients. A standard 3+3 dose-escalation design will be used for Part 1 in order to determine the MTD and/or recommended dose for expansion (RDE). Part 2 will consist of 3 cohorts from one or more selected tumor types. Each cohort will enroll 15 patients. The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3-6 weeks), and a Follow-up Period (visits approximately every 12 weeks for up to 2 years after treatment discontinuation).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ADCT-601	Intravenous (IV)

Timeline

• Start date: 2018-12-21
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2018-10-09
• Last updated: 2020-05-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study