Safety Study of SEA-CD40 in Cancer Patients

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    470
  • sponsor
    Seagen Inc.
Updated on 21 March 2021
paclitaxel
cancer
combination therapy
lymphoma
monoclonal antibodies
systemic therapy
measurable disease
treatment regimen
progressive disease
gemcitabine
pembrolizumab
monoclonal antibody therapy
primary cancer
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
adenocarcinoma
solid tumour
solid tumor
solid neoplasm
large b-cell lymphoma
anti-cd20 monoclonal antibody
chemoimmunotherapy
advanced malignant solid tumor
administration intravenous
salvage therapy
indolent lymphoma
ductal adenocarcinoma
classical hodgkin lymphoma
pancreatic ductal adenocarcinoma
sea-cd40

Summary

This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Description

The study will be conducted in the following parts:

Part A: Intravenous (IV) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.

Part B: IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part A.

Part C: IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.

Part D: IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part C.

Part E: Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD and/or the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors.

Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD determined in Part E.

Part G: Subcutaneous (SC) injection (injected under the skin) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors.

Part H: SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part G.

(Note: There is no Part I)

Part J: SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas.

Part K: SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part J.

Part L: Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD and/or OBD. An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used.

In Parts A, C, E, G, and J, a maximum feasible dose (MFD) will be defined if an MTD and/or OBD cannot be identified. Parts B, D, F, H, K. and L will explore the recommended dosing regimen once the MTD and/or OBD, or MFD (if the MTD and/or OBD cannot be identified) has been determined.

Details
Condition Non-Small Cell Lung Cancer, Follicular Lymphoma, Hodgkin's Disease, Hematologic Malignancy, Diffuse Large B-Cell Lymphoma, Blood disorder, Lymphoma, Metastasis, Cancer, Carcinoma, melanoma, Squamous cell carcinoma, skin cancer, Lymphoproliferative Disorder, Lymphoma, B-Cell Lymphoma, Squamous Cell Neoplasms, head and neck cancer, Metastatic Melanoma, Vulvar Dysplasia and Carcinoma, Non-Hodgkin's Lymphoma, Liver Metastases, Bone Metastases, Lymphoma, B-Cell, Cancer/Tumors, Pancreatic Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck, Brain Metastases, Ewing's Family Tumors, Squamous Cell Carcinoma of Head and Neck, Non-Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, Advanced Malignancies, Non Small Cell Lung Cancer Metastatic, Cancer (Pediatric), Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Blood Cancer, Malignant Melanoma, Metastatic Cancer, Neoplasms, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, Neoplasm Metastasis, Lymphoproliferative disorders, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, Non-small Cell Carcinoma, primary cancer, primary malignant neoplasm, non-hodgkin's lymphoma (nhl), squamous cell cancers, malignancy, cancers, malignancies, malignant tumor, malignant tumors, lymphomas, nsclc, b-cell lymphomas, b cell lymphomas, b cell lymphoma, epidermoid carcinoma, squamous cell cancer, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, carcinomas, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies, metastases, metastatic disease, secondary cancer, secondaries, metastatic tumor, metastasized
Treatment Gemcitabine, Pembrolizumab, Nab-paclitaxel, SEA-CD40 monotherapy regimen, IV SEA-CD40 monotherapy regimen, SC SEA-CD40 monotherapy regimen, Intravenous (IV) SEA-CD40, Subcutaneous (SC) SEA-CD40
Clinical Study IdentifierNCT02376699
SponsorSeagen Inc.
Last Modified on21 March 2021

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