A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of Loncastuximab Tesirine and Durvalumab in Patients With Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Status: Terminated
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this phase 1 study is to evaluate the safety and anti-tumor activity of Loncastuximab Tesirine (ADCT-402) and Durvalumab in participants with Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Male or female participants aged 18 years or older

• Pathologic diagnosis of DLBCL, MCL, or FL

• Participants must have relapsed or refractory disease and have failed or been intolerant to standard therapy

• Participants who have received previous CD19-directed therapy must have a biopsy that shows CD19 expression after completion of the CD19-directed therapy

• Measurable disease as defined by the 2014 Lugano Classification

• Participants must be willing to undergo tumor biopsy

• ECOG performance status 0-1

• Screening laboratory values within the following parameters:

∙ Absolute neutrophil count (ANC) ≥1.0 × 103/µL (off growth factors at least 72 hours)

‣ Platelet count ≥75 × 103/µL without transfusion in the past 7 days

‣ Hemoglobin ≥9.0 g/dL (5.59 mmol/L), transfusion allowed

‣ Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and GGT ≤2.5 × the upper limit of normal (ULN)

‣ Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)

‣ Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft-Gault equation

• Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 3 days prior to start of study drug on C1D1 for women of childbearing potential

⁃ Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of study therapy

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Colorado
UCH-MHS Memorial Hospital Centeral
Colorado Springs
Florida
University of Florida Health Shands Cancer Hospital
Gainesville
University of Miami - Sylvester Comprehensive Cancer Center
Miami
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
New York
Icahm School of Medicine at Mount Sinai
New York
Texas
Baylor University Medical Center
Dallas
Joe Arrington Cancer Research and Treatment Center
Lubbock
Baylor Scott & White Medical Center - Temple
Temple
Other Locations
Spain
Hospital Clinic de Barcelona
Barcelona
Hospital General Universitario Gregorio Marañon Pabellón de Oncología
Madrid
Hospital Universitario Fundación Jiménez Díaz Unidad de Limfomas Servicio de Hematologia
Madrid
Hospital Universitario Virgen Del Rocio
Sevilla
Hospital Universitario Virgen Macarena Servicio Oncologia Medica
Sevilla
Time Frame
Start Date: 2019-02-04
Completion Date: 2020-10-27
Participants
Target number of participants: 13
Treatments
Experimental: ADCT-402
Dose escalation phase: Ascending doses of Loncastuximab tesirine will be administered using a traditional 3+3 design. Dose level 1: 90 µg/kg, every 3 weeks (Q3W). Dose level 2: 120 µg/kg, Q3W. Dose level 3: 150 µg/kg, Q3W. Loncastuximab tesirine will be given for 2 doses, 3 weeks apart.~Dose expansion phase: Loncastuximab tesirine will be administered at the recommended dose determined in the dose escalation phase. Durvalumab will also be administered at a dose of 1500 mg once every 4 weeks (Q4W) throughout the dose escalation phase and dose expansion phase.
Sponsors
Leads: ADC Therapeutics S.A.

This content was sourced from clinicaltrials.gov