NCT04440943

A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	CDX-527	CDX-527 is administered by infusion every 2 weeks

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-04-06
• Completion: 2023-04-06
• First posted: 2020-06-22
• Last updated: 2023-06-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study