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Hodgkin DiseasePhase 1NCT06254495

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

A Phase 1 study testing PF-08046044/SGN-35C in people with Hodgkin Disease and Lymphoma, T-Cell, Peripheral, run by Seagen, a wholly owned subsidiary of Pfizer at 33 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046044/SGN-35C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
33 sitesin 6 countries
Study dates
28 May 2024to 13 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

33 sites in 6 countries.

33 sites in 6 countries

United States27 sites

  • Nebraska Medicine - Bellevue Medical Center

    Bellevue, Nebraska, 68123

  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida, 33442

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

    Duarte, California, 91010

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

    Duarte, California, 91010

  • The University of Kansas Cancer Center, Investigational Drug Services

    Fairway, Kansas, 66205

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Sylvester Comprehensive Cancer Center - Hollywood

    Hollywood, Florida, 33021

  • The University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

  • The University of Kansas Medical Center Medical Office Building

    Kansas City, Kansas, 66160

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

    Lee's Summit, Missouri, 64064

  • Griffin Cancer Research Building (GCRB)

    Miami, Florida, 33136

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

    Miami, Florida, 33136

  • University Of Miami Hospitals And Clinics

    Miami, Florida, 33136

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida, 33176

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Nebraska Medicine - Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas, 66211

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Research Center | Seattle, WA

    Seattle, Washington, 98109

  • University of Washington

    Seattle, Washington, 98195

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

United Kingdom2 sites

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust (RM)

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Denmark1 site

  • Rigshospitalet University Hospital of Copenhagen

    Copenhagen Ø, DK 2100

Other trials in Denmark

France1 site

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy1 site

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

    Verona, 37134

Other trials in Italy

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

About this study

Official title: A Phase 1, Open-label Study to Evaluate PF-08046044/SGN-35C in Adults With Advanced Malignancies.

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.

Read more

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.

Being tested
PF-08046044/SGN-35C
Keywords
cHL, PTCL, sALCL, DLBCL, Seattle Genetics, ADC, Anti Drug Conjugate
Medical subject headings
Hodgkin Disease, Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08046044/SGN-35CDrug

    Given into the vein (IV; intravenously)

Study groups in NCT06254495
Study groupRoleWhat they receive
PF-08046044/SGN-35CExperimentalPF-08046044/SGN-35C Monotherapy
Receives: Drug: PF-08046044/SGN-35C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Number of participants with laboratory abnormalities

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

  3. Number of participants with dose modifications due to AEs

    Measured: Up to approximately 1 year

  4. Number of participants with dose-limiting toxicities (DLTs)

    Measured: Up to 21 days

  5. Number of participants with DLTs by dose level

    Measured: Up to 21 days

Secondary outcomes (9)

  1. Number of participants with antidrug antibodies (ADA)

    To be summarized using descriptive statistics

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

  2. Area under the concentration time curve (AUC)

    To be summarized using descriptive statistics

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

  3. Maximum concentration (Cmax)

    To be summarized using descriptive statistics

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

  4. Time at which the maximum concentration occurs (Tmax)

    To be summarized using descriptive statistics

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

  5. Apparent terminal half-life (t1/2)

    To be summarized using descriptive statistics

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

  6. Trough concentration (Ctrough)

    To be summarized using descriptive statistics

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

  7. Objective response rate (ORR) as assessed by the investigator

    A participant is determined to have an objective response if, based on Lugano criteria (Cheson 2014), they achieve a complete response (CR) or partial response (PR) as assessed by the investigator. The ORR is defined as the percentage of participants with an objective response.

    Measured: Up to approximately 1 year

  8. CR rate as assessed by the investigator

    CR rate is defined as the proportion of participants with CR.

    Measured: Up to approximately 1 year

  9. Duration of response (DOR)

    DOR is defined as the time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per Lugano criteria (Cheson 2014) as assessed by the investigator or to death due to any cause, whichever comes first.

    Measured: Up to approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start28 May 2024
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2026

Why it stopped: The trial was terminated for strategic reasons due to portfolio reprioritization. The decision was not based on any safety or regulatory concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06254495
Sponsor's protocol ID
SGN35C-001
Other IDs
C5801001, 2023-505813-26-00, 2023
Status last verified
Jul 2026
First submitted
2 Feb 2024
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08046044/SGN-35C in people with Hodgkin Disease and Lymphoma, T-Cell, Peripheral, run by Seagen, a wholly owned subsidiary of Pfizer at 33 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, United Kingdom, Denmark, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was terminated for strategic reasons due to portfolio reprioritization. The decision was not based on any safety or regulatory concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Through 30-37 days after last study treatment, approximately 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06254495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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