A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers
NCT ID: NCT06254495
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
57 participants
INTERVENTIONAL
2024-05-28
2029-04-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety Study of PF-08046045/SGN-35T in Adults With Advanced Cancers
NCT06120504
A Safety Study of SGN-CD19A for B-Cell Lymphoma
NCT01786135
A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers
NCT06870487
S0349 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT00080847
Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
NCT01190449
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PF-08046044/SGN-35C
PF-08046044/SGN-35C Monotherapy
PF-08046044/SGN-35C
Given into the vein (IV; intravenously)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-08046044/SGN-35C
Given into the vein (IV; intravenously)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
Duarte, California, United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, United States
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University Of Miami Hospitals And Clinics
Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Nebraska Medicine - Bellevue Medical Center
Bellevue, Nebraska, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Nebraska Medicine - Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center | Seattle, WA
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Rigshospitalet University Hospital of Copenhagen
Copenhagen Ø, , Denmark
Institut Gustave Roussy
Villejuif, , France
Centro Ricerche Cliniche di Verona s.r.l.
Verona, , Italy
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
The Royal Marsden NHS Foundation Trust (RM)
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C5801001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505813-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGN35C-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.