A Phase 1 Study of CDX-1140, a Fully Human Agonist Anti-CD40 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Study Name
A Phase 1 Study of CDX-1140, a Fully Human Agonist Anti-CD40 Monoclonal Antibody, in Patients With Advanced Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
NCT03329950
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Immunotherapy
Study Center
Institution Name
HonorHealth Research Insititute
Institution Address
10510 N. 92nd Street
City
Scottsdale
State
Arizona
Zip Code
85258
Phone
(480) 323-1350
List additional Institutions (include address, phone number, and website)
Icahn School of Medicine at Mount Sinai (New York, NY 10029. 212-824-8449).
Memorial Sloan Kettering Cancer Center (New York, NY 10065. 646-888-4384)
Providence Portland Medical Center (Portland, OR 97213. 503-215-7192)
Abramson Cancer Center at the University of Pennsylvania (Philadelphia, PA 19104. 215-614-7677)
Study Contacts
Principal Investigator
Michael Gordon, MD
P.I. Phone
(480) 323-1350
P.I. Email
michael.gordon@honorhealth.com
List additional Principal Investigators (include phone number and email)
Nina Bhardwaj, MD at Mount Sinai (contact Melissa Diamond at 212-824-8449 or melissa.diamond@mssm.edu)
Danny Khalil, MD at Memorial Sloan Kettering (contact 646-888-4384 or khalild@mskcc.org)
Rachel Sanborn, MD at Providence Portland Medical Center (contact Tara Foote at 503-215-7192 or tara.foote@providence.org)
Mark O’Hara, MD at UPenn (contact Sagan Loburak at 215-614-7677 or sagan.loburak.uphs.upenn.edu)
Study Coordinator
Monica Fulk, RN
Study Coordinator Phone
(480) 323-1350
Study Coordinator Email
monica.fulk@honorhealth.com
List additional Study Coordinators (include phone number and email)
Melissa Diamond at 212-824-8449 or melissa.diamond@mssm.edu
Tara Foote at 503-215-7192 or tara.foote@providence.org
Sagan Loburak at 215-614-7677 or sagan.loburak.uphs.upenn.edu
OVERVIEW – in layman’s terms (150 words max)
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 and to further evaluate its safety, tolerability, and efficacy in expansion cohorts once the MTD is determined.
Enrollment
105
Study Start Date
12/01/2017
Estimated Completion Date
12/31/2020
Inclusion Criteria – Patients Must:
  • Have histologically confirmed diagnosis of one of the following cancers: melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian, head and neck, and cholangiocarcinoma
  • Have received all standard therapies for the tumor type: 1. Must have had all standard approved and unapproved therapies as deemed appropriate by the treating physician. 2. Patients are not required to have all approved therapies in a drug class (e.g., patients with kidney cancer do not need all tyrosine kinase inhibitors, patients with melanoma do not need all approved checkpoint blockade inhibitors) 3. Patients who refuse standard therapy are excluded from the study
  • Have measurable disease.
  • Life expectancy ≥ 12 weeks.
  • If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment.
  • Be willing to undergo a tumor biopsy prior to treatment.
  • Be willing to undergo a tumor biopsy while on study treatment.
Exclusion Criteria – Patients Must NOT:
  • Have a history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Have previous treatment with any anti-CD40 antibody.
  • Have received any antibody targeting T-cell check point or co-stimulation pathways within 4 weeks, received any other monoclonal antibody within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor) within 2 weeks prior to study treatment.
  • Have chemotherapy within 21 days (6 weeks for nitrosoureas) or at least 5 half-lives (whichever is longer) prior to study treatment.
  • Receive any kinase inhibitors within 2 weeks prior to study treatment.
  • Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeksprior to study treatment.
  • Have major surgery within 4 weeks prior to study treatment.
  • Use immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
  • Have other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.
  • Have active, untreated central nervous system metastases.
  • Have active autoimmune disease or documented history of autoimmune disease.
  • Have active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or Hepatitis C.
  • Have significant cardiovascular disease including Congestive Heart Failure or poorly controlled hypertension
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Pre-treatment biopsy, agree to on-treatment biopsy, and routine labs
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