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Lymphoma, T-Cell, CutaneousPhase 1NCT06120504

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

A Phase 1 study testing PF-08046045 in people with Lymphoma, T-Cell, Cutaneous and Hodgkin Disease, run by Seagen, a wholly owned subsidiary of Pfizer at 16 sites in 2 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 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046045
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
16 sitesin 2 countries
Study dates
29 Feb 2024to 10 Dec 2025
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

  • 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.
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  • 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.
  • Fluorodeoxyglucose positron emission tomography (FDG PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral CT preferred) per Lugano criteria at baseline (Cheson 2014) (not applicable for subjects with PCL).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States15 sites

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

  • MSK Commack.

    Commack, New York, 11725

  • University of Miami Hospital and Clinics - Lennar

    Coral Gables, Florida, 33146

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MSK Westchester.

    Harrison, New York, 10604

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, 33136

  • MSK Monmouth.

    Middletown, New Jersey, 07748

  • MSK Bergen.

    Montvale, New Jersey, 07645

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

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center-Main Campus

    New York, New York, 10065

  • Stanford Cancer Center / Blood and Marrow Transplant Program

    Palo Alto, California, 94304

  • Hackensack University Medical Center (From Road)

    Paramus, New Jersey, 07652

  • MSK Nassau.

    Uniondale, New York, 11553

Other trials in United States

Spain1 site

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

Other trials in Spain

About this study

Official title: An Open-label Phase 1 Study to Evaluate the Safety of PF-08046045/SGN-35T in Adults With Advanced Malignancies

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.

Read more

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.

Read the detailed description

This is a phase 1, open-label, multicenter study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-08046045/SGN-35T in adults with select relapsed/refractory lymphomas. PF-08046045 is a CD30-directed antibody-drug conjugate and will be studied in patients with lymphomas expressing CD30.

Being tested
PF-08046045
Keywords
cHL, ALCL, PCL, PTCL, DLBCL, CTCL, Non-Hodgkin Lymphoma, Seattle Genetics
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Hodgkin Disease, Lymphoma, T-Cell, Peripheral, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

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

  • PF-08046045Drug

    Also called SGN-35T

    Given into the vein (IV; intravenously)

Study groups in NCT06120504
Study groupRoleWhat they receive
PF-08046045Experimentalmonotherapy
Receives: Drug: PF-08046045

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 (7)

  1. Pharmacokinetic (PK) parameter - 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

  2. PK parameter - Maximum concentration (Cmax)

    To be summarized using descriptive statistics

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

  3. PK parameter - Time to Cmax (Tmax)

    To be summarized using descriptive statistics

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

  4. 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

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

    A subject is determined to have an objective response if, based on disease-specific assessment criteria, 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

  6. Complete response (CR) rate as assessed by the investigator

    CR rate is defined as the percentage of subjects with CR.

    Measured: Up to approximately 1 year

  7. 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 disease-specific assessment criteria 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 posted7 Nov 2023
  2. Study start29 Feb 2024
  3. Primary completion10 Dec 2025
  4. Study completion10 Dec 2025

Why it stopped: Study terminated as part of strategic considerations

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120504
Sponsor's protocol ID
SGN35T-001
Other IDs
C5811001, 2022-502390-41-00
Status last verified
Jul 2026
First submitted
2 Nov 2023
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-08046045 in people with Lymphoma, T-Cell, Cutaneous and Hodgkin Disease, run by Seagen, a wholly owned subsidiary of Pfizer at 16 sites in 2 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 16 inclusion and 10 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 16 sites in United States, Spain. 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: Study terminated as part of strategic considerations). 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 NCT06120504.

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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