A Study of CDX-1140 in Patients With Advanced Solid Tumors

A Study of CDX-1140 in Patients With Advanced Solid Tumors

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Not Yet Recruiting.

https://clinicaltrials.gov/ct2/show/NCT03329950

Study Type:
Interventional
Study Design:
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:
A Phase 1 Study of CDX-1140, a Fully Human Agonist Anti-CD40 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer
Genetic and Rare Diseases Information Center resources: Esophageal Cancer Ovarian Cancer Renal Cell Carcinoma Stomach Cancer Transitional Cell Carcinoma Bile Duct Cancer
U.S. FDA Resources

Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:Safety and Tolerability of CDX1140-01 as assessed by CTCAE v4.0 [ Time Frame: Within 28 days after first dose ]The rates of drug-related adverse events, serious drug-related adverse events, dose-limiting toxicities, laboratory test abnormalities, and maximum tolerated dose will be determined.

Estimated Enrollment:
105
Anticipated Study Start Date:
November 2017
Estimated Study Completion Date:
December 2020
Estimated Primary Completion Date:
July 2020 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: CDX-1140Dose-escalation phase: Eligible patients will receive treatments, based on cohort assigned, in 4 week cycles until progression or intolerance.

Expansion phase: To further study the safety, tolerability, and efficacy of CDX-1140. Patients enrolled in the expansion phase of the study will receive CDX-1140 at the dose level(s) chosen during the escalation phase.
Drug: CDX-1140CDX-1140 will be administered every 4 weeks.

Detailed Description:CDX-1140 is a fully human monoclonal antibody that binds to a cell receptor called CD40 found on certain cells to activate the immune system which may promote anti-tumor effects.

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several levels of CDX-1140. The first part of the study will test the safety profile of CDX-1140 and determine which dose(s) of CDX-1140 will be studied in the expansion portion of the study.

Up to 105 patients will be enrolled. 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.
Eligibility
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:
18 Years and older   (Adult, Senior)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:

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
Receipt of all standard therapies for the tumor type:

Must have had all standard approved and unapproved therapies as deemed appropriate by the treating physician.
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)
Patients who refuse standard therapy are excluded from the study
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.
Willingness to undergo a tumor biopsy prior to treatment.
Willingness to undergo a tumor biopsy while on study treatment.
Exclusion Criteria:

History of severe hypersensitivity reactions to other monoclonal antibodies.
Previous treatment with any anti-CD40 antibody.
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.
Chemotherapy within 21 days (6 weeks for nitrosoureas) or at least 5 half-lives (whichever is longer) prior to study treatment.
Received 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 weeks prior to study treatment.
Major surgery within 4 weeks prior to study treatment.
Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
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.
Active, untreated central nervous system metastases.
Active autoimmune disease or documented history of autoimmune disease.
Active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or Hepatitis C.
Significant cardiovascular disease including Congestive Heart Failure or poorly controlled hypertension.
Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329950

Contacts

Contact: Celldex Therapeutics
844-723-9363
info@celldex.com
Locations

United States, Arizona
HonorHealth Research Insititute
Not yet recruiting
Scottsdale, Arizona, United States, 85258
Contact: Michael Gordon, MD
Principal Investigator: Michael Gordon, MD
United States, New York
Mount Sinai School of Medicine
Not yet recruiting
New York, New York, United States, 10029
Contact: Nina Bhardwaj, MD
Principal Investigator: Nina Bhardwaj, MD
Memorial Sloan Kettering Cancer Center
Not yet recruiting
New York, New York, United States, 10065
Contact: Danny Khalil, MD
Principal Investigator: Danny Khalil, MD
United States, Oregon
Providence Portland Medical Center
Not yet recruiting
Portland, Oregon, United States, 97213
Contact: Rachel Sanborn, MD
Principal Investigator: Rachel Sanborn, MD
United States, Pennsylvania
Abramson Cancer Center at the University of Pennsylvania
Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sagan Loburak    215-614-7677    Sagan.Loburak@uphs.upenn.edu
Contact: Jennifer Louie    215-220-9668    Jennifer.Louie2@uphs.upenn.edu
Principal Investigator: Mark O’Hara, MD
Sponsors and Collaborators
Celldex Therapeutics
More Information

Responsible Party:
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT03329950     History of Changes
Other Study ID Numbers:
CDX1140-01

First Submitted:
October 23, 2017
First Posted:
November 2, 2017
Last Update Posted:
November 2, 2017
Last Verified:
October 2017

Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No