A Phase 1, Open-label Study to Evaluate PF-08046044/SGN-35C in Adults With Advanced Malignancies.

Status: Active_not_recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
Duarte
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte
University of California, San Francisco Medical Center
San Francisco
Florida
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood
Sylvester Comprehensive Cancer Center - Kendall
Miami
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami
University Of Miami Hospitals And Clinics
Miami
Kansas
The University of Kansas Cancer Center, Investigational Drug Services
Fairway
University of Kansas Clinical Research Center
Fairway
The University of Kansas Hospital
Kansas City
The University of Kansas Hospital Cambridge North Tower A
Kansas City
The University of Kansas Medical Center Medical Office Building
Kansas City
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park
The University of Kansas Cancer Center - Overland Park
Overland Park
University of Kansas Cancer Center
Westwood
Missouri
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit
Nebraska
Nebraska Medicine - Bellevue Medical Center
Bellevue
Nebraska Medical Center
Omaha
Nebraska Medicine - Village Pointe
Omaha
University of Nebraska Medical Center
Omaha
New Jersey
Robert Wood Johnson University Hospital
New Brunswick
Rutgers Cancer Institute of New Jersey
New Brunswick
Texas
South Texas Accelerated Research Therapeutics, LLC
San Antonio
Washington
Fred Hutchinson Cancer Research Center | Seattle, WA
Seattle
University of Washington
Seattle
Other Locations
Denmark
Rigshospitalet University Hospital of Copenhagen
Copenhagen Ø
France
Institut Gustave Roussy
Villejuif
Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona
Spain
Hospital Universitari Vall d'Hebron
Barcelona
United Kingdom
The Royal Marsden NHS Foundation Trust (RM)
London
The Christie NHS Foundation Trust
Manchester
Time Frame
Start Date: 2024-05-28
Completion Date: 2029-04-18
Participants
Target number of participants: 57
Treatments
Experimental: PF-08046044/SGN-35C
PF-08046044/SGN-35C Monotherapy
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov

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