A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04440943|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : February 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Breast Cancer Gastric Cancer Renal Cell Carcinoma Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Cholangiocarcinoma Bladder Urothelial Carcinoma MSI-H Colorectal Cancer Esophageal Cancer Hepatic Cancer Head and Neck Cancer Other Solid Tumors||Drug: CDX-527||Phase 1|
This study will determine the safety, tolerability and activity of CDX-527.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study.
The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation
Up to 40 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies|
|Actual Study Start Date :||August 4, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||January 2023|
Dose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance.
Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase.
CDX-527 is administered by infusion every 2 weeks
- Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0 [ Time Frame: From first dose through 28 days after last dose ]The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
- Objective Response Rate [ Time Frame: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years. ]The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
- Clinical Benefit Rate [ Time Frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years. ]The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
- Duration of Response [ Time Frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years) ]The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
- Progression-free Survival [ Time Frame: From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years) ]The time from start of study drug to time of progression or death, whichever occurs first
- Overall Survival [ Time Frame: The time from start of study drug to death from any cause (up to approximately 1-2 years) ]The time from start of study drug to death
- Immunogenicity Evaluation [ Time Frame: Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose ]Serum samples will be obtained for assessment of human anti-CDX-527 antibodies
- Pharmacokinetic Evaluation [ Time Frame: Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose ]CDX-527 serum concentrations will be measured at specified visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440943
|Contact: Celldex Therapeutics||(844) email@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Contact: Anila Lokhandwala 404-236-8124|
|Principal Investigator: Rodolfo Bordoni, MD|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Jose Torio firstname.lastname@example.org|
|Principal Investigator: Gini Fleming, MD|
|United States, North Carolina|
|Duke Cancer Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Duke Center for Cancer Immunotherapy Clinical Trials Office 919-681-6468 CCI-ImmunoOnc@duke.edu|
|Principal Investigator: Mustafa Khasraw, MD|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Christina Lopez 503-215-2614 CanRsrchStudies@providence.org|
|Principal Investigator: Rachel Sanborn, MD|