NCT05788484

A Study of CDX-585 in Patients With Advanced Malignancies

A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 in patients with cancer. Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-585. The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study. 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. The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study.

Conditions

• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer
• Bladder Urothelial Carcinoma
• Colorectal Cancer
• Esophageal Cancer
• Hepatic Cancer
• Renal Cell Carcinoma
• Cholangiocarcinoma
• Pancreatic Cancer
• Other Solid Tumors

Interventions

Type	Name	Description
DRUG	CDX-585	CDX-585 is administered by infusion every 2 weeks

Timeline

• Start date: 2023-05-11
• Primary completion: 2025-05-21
• Completion: 2025-05-21
• First posted: 2023-03-29
• Last updated: 2025-06-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study