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

Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called SGN-35T for adults with advanced forms of lymphoma, a type of cancer that affects the blood cells responsible for fighting infections. The trial aims to determine how safe SGN-35T is and to identify any side effects that may occur. It is particularly focused on patients with specific types of lymphoma, such as classical Hodgkin lymphoma and peripheral T-cell lymphoma, who have not found success with other treatments.

To be eligible for the trial, participants should have a confirmed diagnosis of one of the lymphoma types being studied and must have had little to no success with standard therapies. This study will involve several visits where patients will receive SGN-35T through an infusion. Throughout the trial, participants will be closely monitored for the drug's effects and any side effects that may arise. It’s important to note that SGN-35T is still being tested and has not yet been approved for general use.

Gender

ALL

Eligibility 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.