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

Who is this study for? Adult patients with Recurrent, Locally Advanced, or Metastatic Melanoma, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, and others
What treatments are being studied? CDX-1140
Status: Completed
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Recurrent, locally advanced or metastatic melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian fallopian or primary peritoneal carcinoma, head and neck, and cholangiocarcinoma. Additional tumor types (except primary CNS tumors) may be enrolled after discussion with, and approval from, the medical monitor.

• Must have received all standard of care therapies (approved or unapproved) as deemed appropriate by the treating physician. Patients who refuse standard therapy are excluded from the study.

• If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment

• Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

⁃ Additional Inclusion Criteria for Part 1:

• Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent B-cell lymphoma are also eligible.

• Lymphoma patients must have received ≥ 1 prior systemic therapy

⁃ Additional Inclusion Criteria for Part 3:

• Patients must have documented progression while receiving anti-PD-1 or anti-PD-L1 based regimens for FDA approved indications

• Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen

⁃ Additional Inclusion Criteria for Part 4:

• Patients must have metastatic pancreatic adenocarcinoma, and have not received previous treatment in a metastatic setting

Locations
United States
Arizona
HonorHealth Research Insititute
Scottsdale
Georgia
Northside Hospital, Inc.
Atlanta
Georgia Cancer Center at Augusta University
Augusta
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha
New York
Icahn School of Medicine at Mount Sinai
New York
Memorial Sloan Kettering Cancer Center
New York
Ohio
Gabrail Cancer Center Research LLC
Canton
Oregon
Providence Portland Medical Center
Portland
Pennsylvania
Abramson Cancer Center at the University of Pennsylvania
Philadelphia
Rhode Island
Rhode Island Hospital (RIH) The Miriam Hospital (TMH)
Providence
Texas
Houston Methodist
Houston
Time Frame
Start Date: 2017-12-01
Completion Date: 2022-09-13
Participants
Target number of participants: 132
Treatments
Experimental: CDX-1140 and chemotherapy
Part 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care.
Experimental: CDX-1140
Part 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment.
Experimental: CDX-1140 and CDX-301
Part 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.
Experimental: CDX-1140 and pembrolizumab
Part 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Celldex Therapeutics

This content was sourced from clinicaltrials.gov

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