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Brief Title: A 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

INTRODUCTION

  • Org Study ID: CDX1140-01
  • Secondary ID: Keynote-A23
  • NTC ID: NCT03329950
  • Sponsor: Celldex Therapeutics

BRIEF 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.

DETAILED DESCRIPTION

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) 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, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study.

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.

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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: From first dose through 30 days after last 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
  • Follicular Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Waldenstrom's Disease
  • Marginal Zone Lymphoma
  • Mucosa Associated Lymphoid Tissue
  • Small Lymphocytic Leukemia

ELIGIBILITY

Key Inclusion Criteria:
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:
1. Patients must have metastatic pancreatic adenocarcinoma, and have not received previous treatment in a metastatic setting
Key Exclusion Criteria:
History of severe hypersensitivity reactions to other monoclonal antibodies.

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

- Inadequate washout period from prior therapy as defined in the Protocol.

- 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.

- History of (non-infectious) pneumonitis or has current pneumonitis.

- Active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or Hepatitis C.
Additional Exclusion Criteria for lymphoma patients in Part 1:
Prior allogenic stem cell transplantation

- Patients who have received autologous stem cell transplant ≤ 12 weeks prior to the first dose of study drug.
There are additional criteria your study doctor will review with you to confirm your eligibility for the study.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 844-723-9363

Email: info@celldex.com

LOCATION

Facility Status Contact
Facility: HonorHealth Research Insititute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: Contact
Michael Gordon, MD
480-323-1350 208
Michael.Gordon@honorhealth.com
Facility: Northside Hospital, Inc.
Atlanta, Georgia 30342
United States
Status: Recruiting Contact: Contact
Dan Mocan
480-323-3661 213
dmocan@honorhealth.com
Facility: Georgia Cancer Center at Augusta University
Augusta, Georgia 30912
United States
Status: Recruiting Contact: Principal Investigator
Michael Gordon, MD
404-303-3355
clinicaltrials@northside.com
Facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Contact
Rodolfo Bordoni, MD
706-721-1206
kjenkins@augusta.edu
Facility: Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact: Principal Investigator
Rodolfo Bordoni, MD
706-721-5095
ploveday@augusta.edu
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Kelly Jenkins
402-691-6971
mmeays@nebraskacancer.com
Facility: Gabrail Cancer Center Research LLC
Canton, Ohio 44718
United States
Status: Recruiting Contact: Contact
Patricia Loveday
402-691-6972
gpierce@nebraskacancer.com
Facility: Providence Portland Medical Center
Portland, Oregon 97213
United States
Status: Recruiting Contact: Principal Investigator
Vamsi Kota, MD
212-824-7811
Daniela.Delbeau@mssm.edu
Facility: Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Megan Meays
646-888-4384
khalild@mskcc.org
Facility: Rhode Island Hospital (RIH) The Miriam Hospital (TMH)
Providence, Rhode Island 02903
United States
Status: Recruiting Contact: Contact
Gladys Pierce
330-492-3345
csmith@gabrailcancercenter.com
Facility: Houston Methodist
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
Ralph Hauke, MD
330-492-3345
bdessecker@gabrailcancercenter.com