A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers

Stopped early · Phase 1

Conditions studied: Hodgkin Disease, Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic

In brief

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.

Key facts

Study ID

NCT06254495

Run by

Seagen, a wholly owned subsidiary of Pfizer

People needed

58

Starts

2024-05-28

Expected to finish

2026-04-13

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 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
• Griffin Cancer Research Building (GCRB) — Miami, 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

Full record on ClinicalTrials.gov

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