Sponsor: Seagen, a wholly owned subsidiary of Pfizer
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Overview
This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infection. There are several types of lymphoma. This study will enroll people who have classical Hodgkin lymphoma (cHL), peripheral T cell lymphoma (PTCL), or diffuse large B cell lymphoma (DLBCL).
This clinical trial uses a drug called PF-08046044/SGN-35C . The study drug is in testing and has not been approved for sale. This is the first time SGN -35C will be used in people.
This study will test the safety of SGN-35C in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.
This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35C. Part C will use the dose found in parts A and B to find out how safe SGN-35C is and if it works to treat select lymphomas.
Who can participate
Inclusion Criteria:
* Tumor type
* For dose escalation and back fill and dose optimization (Parts A and B):
* Participants with a histologically confirmed lymphoid neoplasm who in the judgement of the investigator have no appropriate standard therapy available at the time of enrollment and are a candidate for PF-08046044/SGN- 35C treatment. Eligible subtypes and treatment status are as follows:
* Participants with relapsed/refractory (R/R) cHL: should have received at least 3 prior systemic therapies including autologous stem cell transplant \[ASCT\] (ASCT and the associated high-dose chemotherapy prior to ASCT are considered to be 1 prior line, along with post-transplant consolidation if progression has not occurred between transplant and start of consolidation) or an anti-PD-1 agent (or refused/were ineligible); or 2 prior systemic therapies if, according to the investigator, no other appropriate standard treatment is available.
* Participants with R/R PTCL (excluding systematic anaplastic large cell lymphoma \[sALCL\]): should have received at least 2 prior systemic therapies, or 1 prior systemic therapy if, according to the investigator, no other appropriate standard treatment is available.
* Participants with R/R sALCL: should have received at least 2 prior systemic therapies, including 1 brentuximab vedotin-containing regimen, or 1 prior line of systemic therapy including brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone.
* Participants with R/R DLBCL: should have received at least 2 prior systemic therapies, including ASCT and chimeric antigen receptor (CAR) T-cell therapy, or were ineligible, or refused.
* Participants with PTCL and DLBCL must have a detectable cluster of differentiation 30 (CD30) expression level (≥1%) in tumor tissue from the most recent biopsy obtained at or after relapse by local testing.
* For dose expansion (Part C):
* Participants are eligible irrespective of CD30 expression on tumor tissue; however, participants must provide tumor tissue for evaluation of CD30 expression from the most recent biopsy obtained at or after relapse.
* Participants with cHL, PTCL, sALCL, and DLBCL: Eligible subtypes are the same as defined in Parts A and B
* If activated, the biology cohort may enroll the populations included in Parts A, B, and C.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
* Fluorodeoxyglucose positron emission tomography (FDG-PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral computed tomography \[CT\] preferred)
Exclusion Criteria:
* Previous exposure to any antibody-drug conjugates (ADCs) with camptothecin-based payload.
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
* Active central nervous system (CNS) disease related to the underlying malignancy. Participants with a history of CNS disease related to the underlying malignancy are allowed if prior CNS disease has been treated and the participant is clinically stable (defined as not currently receiving steroid treatment for symptoms related to cerebral/meningeal disease and with no ongoing related AE).
* Received previous ASCT infusion \<12 weeks prior to the first dose of SGN-35C.
* Previous allogeneic stem cell transplant (SCT) if they meet any of the following criteria:
* \<100 days from allogeneic SCT. Participants ≥100 days from allogeneic SCT who are stable without immunosuppressive therapy for at least 12 weeks are permitted.
* Active acute or chronic graft-versus-host disease (GVHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GVHD.
* History of clinically significant GI bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of trial treatment.
Interventions
PF-08046044/SGN-35C
DRUG
Locations
32
Denmark (1)
Rigshospitalet University Hospital of Copenhagen
Copenhagen Ø
France (1)
Institut Gustave Roussy
Villejuif
Italy (1)
Centro Ricerche Cliniche di Verona s.r.l.
Verona
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona
United Kingdom (2)
The Christie NHS Foundation Trust
Manchester
The Royal Marsden NHS Foundation Trust (RM)
Sutton , Surrey
United States (26)
Nebraska Medicine - Bellevue Medical Center
Bellevue , Nebraska
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables , Florida
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach , Florida
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
Duarte , California
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte , California
The University of Kansas Cancer Center, Investigational Drug Services
Fairway , Kansas
University of Kansas Clinical Research Center
Fairway , Kansas
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood , Florida
The University of Kansas Hospital Cambridge North Tower A
Kansas City , Kansas
The University of Kansas Hospital
Kansas City , Kansas
The University of Kansas Medical Center Medical Office Building
Kansas City , Kansas
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit , Missouri
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami , Florida
University Of Miami Hospitals And Clinics
Miami , Florida
Sylvester Comprehensive Cancer Center - Kendall
Miami , Florida
Robert Wood Johnson University Hospital
New Brunswick , New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick , New Jersey
Nebraska Medical Center
Omaha , Nebraska
Nebraska Medicine - Village Pointe
Omaha , Nebraska
University of Nebraska Medical Center
Omaha , Nebraska
The University of Kansas Cancer Center - Overland Park
Overland Park , Kansas
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park , Kansas
University of California, San Francisco Medical Center
San Francisco , California
Fred Hutchinson Cancer Research Center | Seattle, WA