Safety Study of SEA-CD40 in Cancer Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02376699 |
Recruitment Status :
Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : February 8, 2023
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Hodgkin Disease Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Melanoma Neoplasm Metastasis Neoplasms, Head and Neck Neoplasms, Squamous Cell Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer Metastatic Non-small Cell Carcinoma Squamous Cell Cancer Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Squamous Cell Neoplasm Lymphoma, Non-Hodgkin Pancreatic Adenocarcinoma | Drug: Intravenous (IV) SEA-CD40 Drug: Pembrolizumab Drug: Subcutaneous (SC) SEA-CD40 Drug: Gemcitabine Drug: Nab-paclitaxel | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 159 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies |
Actual Study Start Date : | February 28, 2015 |
Estimated Primary Completion Date : | January 31, 2024 |
Estimated Study Completion Date : | October 31, 2024 |

Arm | Intervention/treatment |
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Experimental: IV Monotherapy in Solid Tumors
SEA-CD40 administered IV
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Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40 |
Experimental: IV Monotherapy in Lymphomas
SEA-CD40 administered IV
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Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40 |
Experimental: Combination Therapy in Solid Tumors
SEA-CD40 (administered IV) + pembrolizumab
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Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40 Drug: Pembrolizumab Given intravenously; schedule is cohort-specific.
Other Name: Keytruda |
Experimental: SC Monotherapy in Solid Tumors
SEA-CD40 administered SC
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Drug: Subcutaneous (SC) SEA-CD40
Given subcutaneously on Day 1 every 3 weeks
Other Name: SEA-CD40 |
Experimental: SC Monotherapy in Lymphomas
SEA-CD40 administered SC
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Drug: Subcutaneous (SC) SEA-CD40
Given subcutaneously on Day 1 every 3 weeks
Other Name: SEA-CD40 |
Experimental: Combination Therapy in Pancreatic Cancer
SEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel
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Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40 Drug: Pembrolizumab Given intravenously; schedule is cohort-specific.
Other Name: Keytruda Drug: Gemcitabine 1000 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
Other Name: Gemzar Drug: Nab-paclitaxel 125 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
Other Name: Abraxane |
- Incidence of adverse events (Parts A-K) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Incidence of laboratory abnormalities (Parts A-K) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Incidence of adverse events (Part L) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- ORR per iRECIST (Part L) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- ORR (Parts A-K) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Disease control rate (All Parts) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Duration of response (All Parts) [ Time Frame: Up to approximately 6 years ]
- Progression-free survival (All Parts) [ Time Frame: Up to approximately 6 years ]
- Overall survival (All Parts) [ Time Frame: Up to approximately 6 years ]
- Cmax (maximum observed concentration) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Tmax (time of maximum observed concentration) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- AUClast (AUC from time 0 to last quantifiable timepoint) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- AUCinf (AUC from time 0 to infinity) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Apparent total clearance [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- T1/2 (apparent terminal elimination half-life) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Incidence of antitherapeutic antibodies against SEA-CD40 [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
- Blood concentrations of SEA-CD40 [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Histologically confirmed advanced malignancy, either: (a) Metastatic or unresectable solid malignancy; or (b) Classical Hodgkin lymphoma (HL), or diffuse large B-cell lymphoma (DLBCL), or indolent lymphoma (including follicular lymphoma [FL])
- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Relapsed, refractory, or progressive disease, specifically: (a) Solid tumors: Following at least 1 prior systemic therapy, and no further standard therapy is available for the patient's advanced solid tumor at the time of enrollment; or (b) Classical HL: Following at least 2 prior systemic therapies in patients who are not candidates for autologous stem cell transplant (SCT), or following failure of autologous SCT; or (c) DLBCL: Following at least 1 prior systemic therapy; patients must have also received intensive salvage therapy unless they refused or were deemed ineligible; or (d) Indolent lymphoma: Following at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists
- (Combination Therapy - Part E and Part F) -- Histologically or cytologically confirmed advanced or metastatic solid malignancy for which pembrolizumab treatment is approved. In Part F, other advanced solid tumor indications may be eligible as identified by the Sponsor.
- (Pancreatic Cancer Cohort - Part L) - Histologically or cytologically confirmed metastatic exocrine ductal adenocarcinoma of the pancreas not amenable to curative therapy. Patients must not have received any prior systemic therapy for metastatic disease; patients who have received prior therapy for non-metastatic pancreatic adenocarcinoma are eligible if therapy was fully completed more than 4 months before start of study treatment.
- Representative baseline tumor tissue sample is available (Parts A-K)
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate baseline hematologic, renal, and hepatic function
- Recovery to Grade 1 of any clinically significant toxicity attributed to prior anticancer therapy prior to initiation of study drug administration
Exclusion Criteria:
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Parts A-K
- Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
- Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
- Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
- Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
- Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
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Part L
- History of radiation pneumonitis
- Neuropathy Grade 2 or higher
- Has received prior therapy with an anti-PD-1, anti-PDL1, or anti-PD-L2 agent, with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has had allogenic tissue/solid organ transplant
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All Parts
- Recent or ongoing serious infections within 2 weeks
- Known positivity for hepatitis B infection
- Known active hepatitis C infection
- Active autoimmune or auto-inflammatory ocular disease within 6 months
- Known or suspected active organ-threatening autoimmune disease
- Active central nervous system tumor or metastases
- Patients with lymphomas: prior allogeneic SCT
- Patients in Part E, F, or L: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376699

Study Director: | Michael Schmitt, MD, PhD | Seagen Inc. |
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT02376699 |
Other Study ID Numbers: |
SGNS40-001 PN 863 ( Other Identifier: Merck Sharp & Dohme Corp ) |
First Posted: | March 3, 2015 Key Record Dates |
Last Update Posted: | February 8, 2023 |
Last Verified: | February 2023 |
CD40 Antigen Drug Therapy Follicular Lymphoma Hodgkin Disease Immunotherapy Indolent Lymphoma Lymphoma Lymphoma, B-Cell |
Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Monoclonal Antibody Neoplasms Neoplasm Metastasis Solid tumor Seattle Genetics |
Lymphoma Carcinoma Lung Neoplasms Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Neoplasm Metastasis Squamous Cell Carcinoma of Head and Neck Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms, Squamous Cell Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Head and Neck Neoplasms |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Neoplastic Processes Pathologic Processes |