TERMINATED

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 cHL ALCL PCL PTCL DLBCL CTCL Non-Hodgkin Lymphoma Seattle Genetics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-label Phase 1 Study to Evaluate the Safety of PF-08046045/SGN-35T in Adults With Advanced Malignancies

Quick Facts

Study Start:2024-02-29

Study Completion:2025-12-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06120504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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 \<12 weeks prior to first PF-08046045 dose. * Participants with 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 or receiving immunosuppressive therapy as treatment for or prophylaxis against graft versus host disease. * Participants with previous allogeneic SCT and participants considered at high risk for CMV reactivation (eg, recent prior CAR-T or bispecific antibody therapy) if they meet the following criteria: Cytomegalovirus (CMV) PCR ≥500 IU/mL, OR rising DNA levels \>5-times baseline within 1 month, OR detectable CMV PCR receiving pre-emptive therapy; prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to the first dose of study intervention. * Grade 2 or higher pulmonary disease unrelated to underlying malignancy, or history of Grade 2 or higher drug-induced interstitial lung disease (ILD) or immune checkpoint inhibitor (ICI)-related ILD. * Clinically significant lung disease requiring systemic corticosteroid treatment within 6 months prior to enrollment or who are suspected to have such diseases via radiographic imaging and/or functional tests conducted during the screening period.

Inclusion Criteria

Exclusion 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).

* 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 \<12 weeks prior to first PF-08046045 dose.
* Participants with 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 or receiving immunosuppressive therapy as treatment for or prophylaxis against graft versus host disease.
* Participants with previous allogeneic SCT and participants considered at high risk for CMV reactivation (eg, recent prior CAR-T or bispecific antibody therapy) if they meet the following criteria: Cytomegalovirus (CMV) PCR ≥500 IU/mL, OR rising DNA levels \>5-times baseline within 1 month, OR detectable CMV PCR receiving pre-emptive therapy; prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to the first dose of study intervention.
* Grade 2 or higher pulmonary disease unrelated to underlying malignancy, or history of Grade 2 or higher drug-induced interstitial lung disease (ILD) or immune checkpoint inhibitor (ICI)-related ILD.
* Clinically significant lung disease requiring systemic corticosteroid treatment within 6 months prior to enrollment or who are suspected to have such diseases via radiographic imaging and/or functional tests conducted during the screening period.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Stanford Cancer Center / Blood and Marrow Transplant Program

Palo Alto, California, 94304

United States

University of Miami Hospital and Clinics - Lennar

Coral Gables, Florida, 33146

United States

University of Miami Hospital and Clinics

Miami, Florida, 33136

United States

University of Miami

Miami, Florida, 33136

United States

MSK Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

MSK Monmouth.

Middletown, New Jersey, 07748

United States

MSK Bergen.

Montvale, New Jersey, 07645

United States

Hackensack University Medical Center (From Road)

Paramus, New Jersey, 07652

United States

MSK Commack.

Commack, New York, 11725

United States

MSK Westchester.

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center-Investigational Drug Service Pharmacy

Long Island City, New York, 11101

United States

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, 10021

United States

Memorial Sloan Kettering Cancer Center-Main Campus

New York, New York, 10065

United States

MSK Nassau.

Uniondale, New York, 11553

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-29

Study Completion Date2025-12-10

Study Record Updates

Study Start Date2024-02-29

Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

cHL
ALCL
PCL
PTCL
DLBCL
CTCL
Non-Hodgkin Lymphoma
Seattle Genetics

Additional Relevant MeSH Terms

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