A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
NCT03329950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2024-03-28
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.
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
- 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 will be administered every 3 weeks.
- DRUG
-
Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Celldex Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-01
- Primary Completion
- 2022-09-13
- Completion
- 2022-09-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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Entities
- Breast Cancer
- Cholangiocarcinoma
- Colorectal Cancer
- Fallopian Tube Cancer
- Follicular Lymphoma
- Gastric Cancer
- Head and Neck Cancer
- Lymphoplasmacytic Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Melanoma
- Non-Hodgkin Lymphoma
- Non-small Cell Lung Cancer
- Ovarian Cancer
- Primary Peritoneal Cancer
- Renal Cell Carcinoma