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

NCT06254495 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: SGN35C-001C58010012023-505813-26-00
• Study Type: interventional
• Target: 57
• Locations: 6 countries
• Sites: 32

Brief Summary

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.

Conditions

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

Keywords

cHL; PTCL; sALCL; DLBCL; Seattle Genetics; ADC; Anti Drug Conjugate

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 (9)

• Number of participants with antidrug antibodies (ADA)

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

• Area under the concentration time curve (AUC)

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

• Maximum concentration (Cmax)

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

• Time at which the maximum concentration occurs (Tmax)

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

• Apparent terminal half-life (t1/2)

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

Study Arms (1)

PF-08046044/SGN-35C

EXPERIMENTAL

PF-08046044/SGN-35C Monotherapy

Drug: PF-08046044/SGN-35C

Interventions

PF-08046044/SGN-35C DRUG

Given into the vein (IV; intravenously)

PF-08046044/SGN-35C

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Seagen, a wholly owned subsidiary of Pfizer: lead

Study Sites (32)

City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)

Duarte, California, 91010, United States

Location

IP Address: City of Hope Investigational Drug Services(IDS)

Duarte, California, 91010, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Coral Gables, Florida, 33146, United States

Location

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, 33021, United States

Location

University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University Of Miami Hospitals And Clinics

Miami, Florida, 33136, United States

Location

Sylvester Comprehensive Cancer Center - Kendall

Miami, Florida, 33176, United States

Location

The University of Kansas Cancer Center, Investigational Drug Services

Fairway, Kansas, 66205, United States

Location

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

Location

The University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, 66160, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, 66160, United States

Location

The University of Kansas Cancer Center - Overland Park

Overland Park, Kansas, 66210, United States

Location

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas, 66211, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

The University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Nebraska Medicine - Bellevue Medical Center

Bellevue, Nebraska, 68123, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Nebraska Medicine - Village Pointe

Omaha, Nebraska, 68118, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Fred Hutchinson Cancer Research Center | Seattle, WA

Seattle, Washington, 98109, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Rigshospitalet University Hospital of Copenhagen

Copenhagen Ø, DK 2100, Denmark

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Centro Ricerche Cliniche di Verona s.r.l.

Verona, 37134, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

The Royal Marsden NHS Foundation Trust (RM)

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; 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: February 2, 2024
• First Posted: February 12, 2024
• Study Start: May 28, 2024
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1); US (26); FR (1); GB (2); DK (1)