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BRIEF TITLE: Study of CDX-1140 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


  • Org Study ID: CDX1140-01
  • Secondary ID:
  • NCT ID: NCT03329950
  • NCT Alias:
  • Sponsor: Celldex Therapeutics - Industry
  • Source: Celldex Therapeutics

Brief Summary

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

Detailed Description


CDX-1140 is a fully human monoclonal antibody that binds to a cell receptor called CD40
expressed on certain cells and which activates the immune system, which then may promote
anti-tumor effects in patients with cancer. CD40 is also expressed on some types of cancer
cells and CDX-1140 may directly cause those cells to die.

CDX-301 is a growth factor for dendritic cells, a key cell type that regulates immune
responses, including anti-tumor immune responses.

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability
and efficacy of CDX-1140 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, and determine which dose(s)
of CDX-1140 will be studied in the expansion portions of the study.

Up to 140 patients will be enrolled for CDX-1140 monotherapy. Up to 40 patients will be
enrolled for CDX-1140 in combination with CDX-301.

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.

Overal Status Start Date Phase Study Type
Recruiting December 1, 2017 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety and Tolerability of CDX-1140 as assessed by CTCAE v5.0

Primary Outcome 1 - Time Frame: Within 35 days after first dose

Condition:

  • 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

Eligibility

Criteria:
Inclusion Criteria:

1. Diagnosed with one of the following:

- 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.

- Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent
B-cell lymphoma

2. Criteria A and B:

A. For patients with solid tumors:

- Must have received all standard of care therapies (approved or unapproved) as
deemed appropriate by the treating physician

- Patients are not required to have all approved therapies in a particular class of
drugs (e.g. all approved tyrosine kinase inhibitors for patients with renal cell
carcinoma or all approved checkpoint blockade antibodies for patients with
melanoma)

- Patients who refuse standard therapy are excluded from the study

B. For patients with lymphoma: Must have received ≥ 1 prior systemic therapy

3. Measurable disease.

4. Life expectancy ≥ 12 weeks.

5. 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.

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

Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies.

2. Previous treatment with any anti-CD40 antibody or with FLT3L.

3. 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.

4. Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient
experienced disease progression on the prior treatment)

5. For lymphoma patients:

- Prior allogenic stem cell transplantation

- Patients who have received autologous stem cell transplant ≤ 12 weeks prior to
the first dose of study drug.

6. Chemotherapy within 21 days (6 weeks for nitrosoureas) or at least 5 half-lives
(whichever is longer) prior to study treatment.

7. Received any kinase inhibitors within 2 weeks prior to study treatment.

8. Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or
radiopharmaceuticals (strontium, samarium) within 8 weeks prior to study treatment.

9. Major surgery within 4 weeks prior to study treatment.

10. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within
2 weeks prior to study treatment.

11. 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.

12. Active, untreated central nervous system metastases.

13. Active autoimmune disease or documented history of autoimmune disease.

14. Active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or
Hepatitis C.

15. Significant cardiovascular disease including Congestive Heart Failure or poorly
controlled hypertension.

There are additional criteria your study doctor will review with you to confirm your
eligibility for the study.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Celldex Therapeutics

Phone: 844-723-9363

Email: info@celldex.com

Locations

Facility Status Contact
HonorHealth Research Insititute
Scottsdale, Arizona 85258
United States
Recruiting Michael Gordon, MD
480-323-1350
Michael.Gordon@honorhealth.com
Northside Hospital, Inc.
Atlanta, Georgia 30342
United States
Recruiting Rodolfo Bordoni, MD
404-303-3355
clinicaltrials@northside.com
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Recruiting Megan Meays
402-691-6971
mmeays@nebraskacancer.com
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Recruiting Daniela Delbeau, MSN, AGCNS-BC, RN
212-824-7811
Daniela.Delbeau@mssm.edu
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Danny Khalil, MD
646-888-4384
khalild@mskcc.org
Gabrail Cancer Center Research LLC
Canton, Ohio 44718
United States
Recruiting Carrie Smith
330-492-3345
csmith@gabrailcancercenter.com
Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting Brenda Fisher, RN
503-215-2613
Brenda.Fisher@providence.org
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Recruiting Sagan Loburak
215-614-7677
Sagan.Loburak@uphs.upenn.edu