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Not recruiting
Phase 1

SGN-35C

Sponsor:

Seagen, a wholly owned subsidiary of Pfizer

Code:

NCT06254495

Conditions

Hodgkin Disease

Lymphoma, T-Cell, Peripheral

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Large-Cell, Anaplastic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08046044/SGN-35C

Study Details

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

Study ID

NCT06254495

Start date

May 28, 2024

Status verified date

Aug, 2025

Completion date

Apr 18, 2029

Anticipated

Primary completion date

Apr 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Design

Enrollment

210 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PF-08046044/SGN-35C

PF-08046044/SGN-35C Monotherapy

Interventions

PF-08046044/SGN-35C

Given into the vein (IV; intravenously)

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days after last study treatment, approximately 1 year ]
  • Number of participants with laboratory abnormalities [ Time Frame: Through 30-37 days after last study treatment, approximately 1 year ]
  • Number of participants with dose modifications due to AEs [ Time Frame: Up to approximately 1 year ]
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]
  • Number of participants with DLTs by dose level [ Time Frame: Up to 21 days ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

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

Recruiting

Duarte, California, United States, 91010

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

Recruiting

Duarte, California, United States, 91010

UCSD Medical Center - Encinitas

Recruiting

Encinitas, California, United States, 92024

UC San Diego / Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

Recruiting

La Jolla, California, United States, 92037

UC San Diego/Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

UCSD Koman Family Outpatient Pavilion

Recruiting

La Jolla, California, United States, 92037

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

UCSD Medical Center - Rancho Bernardo

Recruiting

San Diego, California, United States, 92127

University of California San Francisco | HDFCCC - Hematopoietic Malignancies

Recruiting

San Francisco, California, United States, 94143

UCSD Medical Center - Vista

Recruiting

Vista, California, United States, 92081

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Recruiting

Coral Gables, Florida, United States, 33146

University of Miami Hospital and Clinics - Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Sylvester Comprehensive Cancer Center - Hollywood

Recruiting

Hollywood, Florida, United States, 33021

University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

University Of Miami Hospitals And Clinics

Recruiting

Miami, Florida, United States, 33136

Sylvester Comprehensive Cancer Center - Kendall

Recruiting

Miami, Florida, United States, 33176

The University of Kansas Cancer Center, Investigational Drug Services

Recruiting

Fairway, Kansas, United States, 66205

University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

The University of Kansas Hospital Cambridge Tower A

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Medical Center Medical Office Building

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Cancer Center - Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

The University of Kansas Cancer Center - Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

The University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Nebraska Medicine - Bellevue Medical Center

Recruiting

Bellevue, Nebraska, United States, 68123

Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Nebraska Medicine - Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Fred Hutchinson Cancer Research Center | Seattle, WA

Recruiting

Seattle, Washington, United States, 98109

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Last update posted

Sep 12, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Seagen, a wholly owned subsidiary of Pfizer on 2025-09-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.