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

NCT06120504 | Terminated Phase 1 FDA Drug

• 3 other identifiers: SGN35T-001C58110012022-502390-41-00
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 17

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention

  Through 30-37 days after last study treatment, approximately 1 year

• Number of participants with laboratory abnormalities

  Through 30-37 days after last study treatment, approximately 1 year

• Number of participants with dose modifications due to AEs

  Up to approximately 1 year

• Number of participants with dose-limiting toxicities (DLTs)

  Up to 21 days

• Number of participants with DLTs by dose level

  Up to 21 days

Secondary Outcomes (7)

• Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)

  Through 30-37 days after last study treatment, approximately 1 year

• PK parameter - Maximum concentration (Cmax)

  Through 30-37 days after last study treatment, approximately 1 year

• PK parameter - Time to Cmax (Tmax)

  Through 30-37 days after last study treatment, approximately 1 year

• Number of participants with antidrug antibodies (ADA)

  Through 30-37 days after last study treatment, approximately 1 year

• Objective response rate (ORR) as assessed by the investigator

  Up to approximately 1 year

Study Arms (1)

PF-08046045

EXPERIMENTAL

monotherapy

Drug: PF-08046045

Interventions

PF-08046045 DRUG

Given into the vein (IV; intravenously)

Also known as: SGN-35T

PF-08046045

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seagen, a wholly owned subsidiary of Pfizer: lead

Study Sites (17)

Stanford Cancer Center / Blood and Marrow Transplant Program

Palo Alto, California, 94304, United States

Location

University of Miami Hospital and Clinics - Lennar

Coral Gables, Florida, 33146, United States

Location

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MSK Monmouth.

Middletown, New Jersey, 07748, United States

Location

MSK Bergen.

Montvale, New Jersey, 07645, United States

Location

Hackensack University Medical Center (From Road)

Paramus, New Jersey, 07652, United States

Location

MSK Commack.

Commack, New York, 11725, United States

Location

MSK Westchester.

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center-Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

Location

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

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center-Main Campus

New York, New York, 10065, United States

Location

MSK Nassau.

Uniondale, New York, 11553, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: February 29, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); ES (1)