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Safety evaluation of PF-08046045 in adults with advanced lymphomas

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

Phase 1 Interventional Seagen Inc. · NCT06120504

This study is testing a new drug for adults with advanced lymphomas to see if it's safe and how well it works.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorSeagen Inc. Industry-sponsored
Drugs / interventionsbrentuximab, CAR-T, chemotherapy, cyclophosphamide, doxorubicin, prednisone
Locations36 sites (Little Rock, Arkansas and 35 other locations)
Trial IDNCT06120504 on ClinicalTrials.gov

What this trial studies

This clinical trial is focused on assessing the safety and tolerability of PF-08046045/SGN-35T, a CD30-directed antibody-drug conjugate, in adults with advanced lymphomas, including various types of Hodgkin and peripheral T-cell lymphomas. The study is structured in three parts: the first two parts will determine the optimal dosing and schedule, while the third part will evaluate the drug's effects at the established dose. Participants will receive the drug via infusion, and the study will monitor for side effects and antitumor activity. This is the first time this investigational drug will be administered to humans.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with relapsed or refractory lymphomas that express CD30 and have no appropriate standard therapy available.

Not a fit: Patients with lymphomas that do not express CD30 or those who have access to effective standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced lymphomas who have limited therapeutic alternatives.

How similar studies have performed: Other studies involving CD30-directed therapies have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.
    * 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).

Exclusion Criteria:

* 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.
  * 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.

Where this trial is running

Little Rock, Arkansas and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, T-Cell, CutaneousHodgkin DiseaseLymphoma, T-Cell, PeripheralLymphoma, Large-Cell, AnaplasticLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkincHLALCL
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.