NCT03329950

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

Detailed description

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) 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-1140. The dose-escalation part of the study will test the safety profile of CDX-1140, alone or in combination with CDX-301, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 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.

Conditions

• Melanoma
• Non-small Cell Lung Cancer
• Breast Cancer
• Gastric Cancer
• Renal Cell Carcinoma
• Ovarian Cancer
• Cholangiocarcinoma
• Bladder Urothelial Carcinoma
• Pancreatic Adenocarcinoma
• Colorectal Cancer
• Esophageal Cancer
• Hepatic Cancer
• Head and Neck Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer
• Other Solid Tumors
• Diffuse Large B-cell Lymphoma (DLBCL)
• Mantle Cell Lymphoma
• Indolent B-cell Lymphomas
• Non-Hodgkin Lymphoma
• Follicular Lymphoma
• Lymphoplasmacytic Lymphoma
• Waldenstrom's Disease
• Marginal Zone Lymphoma
• Mucosa Associated Lymphoid Tissue
• Small Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	CDX-1140	CDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3.
DRUG	CDX-301	CDX-301 will be injected once a day for five days before Cycles 1 and 2.
DRUG	pembrolizumab	pembrolizumab will be administered every 3 weeks.
DRUG	Chemotherapy	Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.

Timeline

• Start date: 2017-12-01
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2017-11-06
• Last updated: 2024-03-28

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study