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Terminated NCT06120504

A Safety Study of PF-08046045/SGN-35T in Adults With Advanced Cancers

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 22
Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Location: Stanford Cancer Center / Blood and Marrow Transplant Program Palo Alto California

Summary

This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infections. There are several types of lymphoma. This study will enroll people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or some types of primary cutaneous lymphoma. This clinical trial uses a drug called PF-08046045/SGN-35T. The study drug is in testing and has not been approved for sale. This is the first time PF-08046045 will be used in people. The study drug will be given as an infusion through a vein. This study will test the safety of PF-08046045 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 PF-08046045. Part C will use the dose found in parts A and B to find out how safe PF-08046045 is and if it works to treat select lymphomas.

Eligibility Criteria

Inclusion Criteria: * Disease indication * For dose escalation and dose optimization (Part A and Part B): * Participants with a histologically confirmed lymphoid neoplasm (including relapsed/refractory \[R/R\] classical Hodgkin lymphoma \[cHL\], R/R peripheral T-cell lymphoma \[PTCL\], R/R systemic anaplastic large cell lymphoma \[sALCL\] , R/R mature B-cell neoplasms, and select R/R primary cutaneous lymphomas \[PCLs\]) who in the judgment of the investigator have no appropriate standard therapy available at the time of enrollment and are a candidate for PF-08046045 treatment. * Participants must have a detectable CD30 expression level (≥1%) in tumor tissue (except cHL and ALCL where CD30 is universally expressed). * For dose expansion (Part C) * Participants are eligible irrespective of CD30 expression on tumor tissue. * Participants with cHL: Participants with R/R cHL who have received at least 3 prior systemic therapies (autologous stem cell transplant \[ASCT\] 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) and meet all of the following additional criteria: * Participants who have not received ASCT must have refused or been deemed ineligible. * Participants must have received or been ineligible to receive an anti-PD-1 agent. * Participants with PTCL: * Participants with R/R PTCL (excluding R/R sALCL) who have received at least 2 prior systemic therapies or received at least 1 prior systemic therapy and there is no other available treatment that is considered appropriate by the investigator. * Participants with R/R sALCL must have ALK status documented and must meet one of the following criteria: * Disease recurrence or progression following at least 2 prior systemic therapies where 1 regimen included brentuximab vedotin, or * Disease recurrence or progression following only 1 prior line of therapy which included brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone * An Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1. * Fluorodeoxyglucose positron emission tomography (FDG PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral CT preferred) per Lugano criteria at baseline (Cheson 2014) (not applicable for subjects with PCL). Exclusion Criteria: * Participants who have received more than 2 prior brentuximab vedotin-based lines of therapy. * History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. * Active cerebral/meningeal disease related to the underlying malignancy. * Received previous ASCT infusion \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06120504). StuddyBuddy aggregates publicly available trial information.