A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies
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.
• 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