Safety Study of SEA-CD40 in Cancer Patients
Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Hodgkin Disease
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring 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
Eligibility Criteria
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:
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)
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
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
Sites / Locations
- University of Alabama at Birmingham
- HonorHealth Scottsdale Shea Medical Center
- Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
- Angeles Clinic and Research Institute, The
- Rush University Medical Center
- University of Chicago Medical Center
- University of Michigan Comprehensive Cancer Center
- Karmanos Cancer Institute / Wayne State University
- Mayo Clinic Rochester
- Comprehensive Cancer Centers of Nevada
- Hackensack University Medical Center
- University of New Mexico Cancer Center
- Montefiore Medical Center
- UNC Lineberger Comprehensive Cancer Center / University of North Carolina
- Case Western Reserve University / University Hospitals Cleveland Medical Center
- Providence Portland Medical Center
- MD Anderson Cancer Center / University of Texas
- Utah Cancer Specialists
- Seattle Cancer Care Alliance / University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
IV Monotherapy in Solid Tumors
IV Monotherapy in Lymphomas
Combination Therapy in Solid Tumors
SC Monotherapy in Solid Tumors
SC Monotherapy in Lymphomas
Combination Therapy in Pancreatic Cancer
SEA-CD40 administered IV
SEA-CD40 administered IV
SEA-CD40 (administered IV) + pembrolizumab
SEA-CD40 administered SC
SEA-CD40 administered SC
SEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel