Trials / Terminated

TerminatedNCT03621982

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors

Status: Terminated
Phase: Phase 1
Study type: Interventional
Enrollment: 78 (actual)

Sponsor: ADC Therapeutics S.A. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

Detailed description

This is a Phase 1b, multi-center, open-label study with a dose-escalation part and a dose expansion part. The duration of the study participation for each participant was defined as the time from the date of signed written informed consent to the completion of the followup period, withdrawal of consent, loss to follow-up, or death, whichever occurs first. The study was include a Screening Period (of up to 21 days), a Treatment Period (with cycles of 3 weeks for a Q3W dosing regimen), and a Follow-up Period (approximately every 12 week visits) for up to 1 year after treatment discontinuation.

Conditions

Interventions

Type	Name	Description
DRUG	ADCT-301	intravenous infusion
BIOLOGICAL	Pembrolizumab	intravenous infusion

Timeline

Start date: 2018-11-09
Primary completion: 2022-12-14
Completion: 2022-12-14
First posted: 2018-08-09
Last updated: 2024-06-13
Results posted: 2024-06-13

Locations

9 sites across 3 countries: United States, Belgium, United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03621982. Inclusion in this directory is not an endorsement.