A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Nov 26, 2021
  • participants needed
    260
  • sponsor
    Celldex Therapeutics
Updated on 26 January 2021
metastatic melanoma
paclitaxel
cancer
lymphoma
systemic therapy
carcinoma
lung cancer
pancreatic adenocarcinoma
gemcitabine
pembrolizumab
pd-l1
programmed cell death 1 ligand 1
cancer chemotherapy
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
adenocarcinoma
immunoglobulin
large b-cell lymphoma
cholangiocarcinoma
pancreatic cancers
primary peritoneal carcinoma
peritoneal carcinoma
metastatic pancreatic adenocarcinoma
lung carcinoma
cdx-301

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.

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.

Details
Condition Non-Small Cell Lung Cancer, Adenocarcinoma, Follicular Lymphoma, Ovarian disorder, Colorectal Cancer, Diffuse Large B-Cell Lymphoma, Cholangiocarcinoma, Malignant neoplasm of kidney, Rectal disorder, Lymphoma, Breast Cancer, MALT Lymphoma, Fallopian Tube Cancer, LIVER DISEASE, Ovarian Cancer, Waldenstrom's Macroglobulinemia, Mantle cell lymphoma, Esophageal Diseases, Esophageal Cancer, melanoma, Renal Cell Carcinoma, skin cancer, HEPATIC NEOPLASM, Lymphoma, Neoplasm of unspecified nature of digestive system, Gastropathy, Gastric Cancer, head and neck cancer, Stomach Discomfort, Metastatic Melanoma, Non-Hodgkin's Lymphoma, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Ovarian Function, Solid Tumor, Primary Peritoneal Cancer, Pancreatic Adenocarcinoma, Esophageal Carcinoma, Breast Cancer Diagnosis, Small Lymphocytic Leukemia, Transitional Cell Carcinoma of the Bladder, Other Solid Tumors, Gastric Carcinoma, Recurrent Ovarian Cancer, Bladder Urothelial Carcinoma, Indolent B-cell Lymphomas, Kidney Cancer, Esophageal Disorders, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Stomach Cancer, Liver Disorders, Biliary Tract Cancer, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Waldenstrom's Disease, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, Indolent B-cell Lymphomas, breast carcinoma, clear cell renal cell carcinoma, colorectal neoplasm, transitional cell carcinoma of bladder, non-hodgkin's lymphoma (nhl), ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, gastric cancers, cancer, breast, esophagus cancer, oesophageal cancer, colorectal cancers, cancer, liver, cancer, hepatic, cancer, hepatocellular, liver cancers, diffuse large cell lymphoma, diffuse large b cell lymphoma, nsclc, cancer of the head and neck, fallopian tube cancers, ovarian tumors, cancer, colorectal, colorectal tumor, tumors, colorectal, cancer of the esophagus, oesophageal carcinoma, Indolent B-cell Lymphomas
Treatment Pembrolizumab, Chemotherapy, CDX-1140, CDX-301
Clinical Study IdentifierNCT03329950
SponsorCelldex Therapeutics
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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

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
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