A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, &

Status Withdrawn

Clinical Trial Summary

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, and identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combination therapy.

Clinical Trial Description

This is a Phase 1b, open-label, multi-center study in participants with previously untreated DLBCL, with a dose escalation part followed by dose expansion part. Participants will be treated by loncastuximab tesirine in combination with R CHOP. The duration of the study participation for each participant is defined as the time from the date of signed written informed consent to the completion of the follow-up period, withdrawal of consent, lost to follow-up, or death, whichever occurs first. The study will include a Screening Period (of up to 28 days), a Treatment Period of 6 cycles (cycles of 3 weeks), and a Follow-up Period (approximately every 12 week visits) for up to approximately 3 years from end-of-treatment (EOT). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04974996
Study type	Interventional
Source	ADC Therapeutics S.A.
Contact
Status	Withdrawn
Phase	Phase 1
Start date	February 1, 2022
Completion date	May 5, 2027

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