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New lymphoma drug trial halted early

NCT ID NCT06254495

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This early-stage study tested a new drug, PF-08046044/SGN-35C, in people with advanced lymphomas (Hodgkin and non-Hodgkin types) who had no other treatment options. The main goal was to check safety and find the right dose. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

58 people

The number who actually took part.

Started

May 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anaplastic large cell lymphoma classic Hodgkin lymphoma diffuse large B-cell lymphoma Hodgkins lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hodgkin disease Lymphoma, large B-cell, diffuse Lymphoma, large-cell, anaplastic Lymphoma, T cell, peripheral

Contacts and locations

Locations

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134, Italy

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

    Duarte, California, 91010, United States

  • Fred Hutchinson Cancer Research Center | Seattle, WA

    Seattle, Washington, 98109, United States

  • Griffin Cancer Research Building (GCRB)

    Miami, Florida, 33136, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

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

    Duarte, California, 91010, United States

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Nebraska Medical Center

    Omaha, Nebraska, 68105, United States

  • Nebraska Medicine - Bellevue Medical Center

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine - Village Pointe

    Omaha, Nebraska, 68118, United States

  • Rigshospitalet University Hospital of Copenhagen

    Copenhagen Ø, DK 2100, Denmark

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Sylvester Comprehensive Cancer Center - Hollywood

    Hollywood, Florida, 33021, United States

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida, 33176, United States

  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust (RM)

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas, 66211, United States

  • The University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064, United States

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210, United States

  • The University of Kansas Cancer Center, Investigational Drug Services

    Fairway, Kansas, 66205, United States

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • The University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160, United States

  • The University of Kansas Medical Center Medical Office Building

    Kansas City, Kansas, 66160, United States

  • University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University Of Miami Hospitals And Clinics

    Miami, Florida, 33136, United States

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Washington

    Seattle, Washington, 98195, United States

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