The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

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Hematological Malignancies

CD30-directed Antibody-Tripeptide MMAE Conjugate

PF-08046045, SGN-35T is an investigational compound. Its safety and efficacy have not been established

An Open-label Phase 1 Study to Evaluate the Safety of SGN-35T in Adults With Advanced Malignancies
Phase 1
NCT06120504

Active enrolling

Globe
Locations

United States

Study design

Participant Group/Arm

EXPERIMENTAL: SGN-35T

SGN-35T monotherapy

Intervention/Treatment

DRUG: SGN-35T

Given into the vein (IV; intravenously)

Key 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 SGN-35T treatment.
      • Participants must have a detectable CD30 expression level (≥1%) in tumor tissue (except cHL and ALCL where CD30 is universally expressed).
  • Disease indication
    • 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) 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
  • Previous exposure to CD30 targeted therapy (exception: participants with cHL, PTCL, or PCL may have received prior brentuximab vedotin but no more than 2 prior brentuximab vedotin based lines of therapy and at least 3 months should have elapsed before enrollment).
  • 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 SGN-35T 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 diseas
  • 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 drug.
  • 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.

Key dates

Study start date
  • February 2024
Estimated primary completion date
  • April 2030

Key endpoints

Primary Outcome Measures
Outcome Measure

Number of participants with adverse events (AEs)

Measure Description

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

Time Frame

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

Outcome Measure

Number of participants with laboratory abnormalities

Time Frame

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

Outcome Measure

Number of participants with dose modifications due to AEs

Time Frame

Up to approximately 1 year

Outcome Measure

Number of participants with dose-limiting toxicities (DLTs)

Time Frame

Up to 21 days

Outcome Measure

Number of participants with DLTs by dose level

Time Frame

Up to 21 days

Secondary Outcome Measures:
Outcome Measure

Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)

Measure Description

To be summarized using descriptive statistics

Time Frame

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

Outcome Measure

PK parameter - Maximum concentration (Cmax)

Measure Description

To be summarized using descriptive statistics

Time Frame

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

Outcome Measure

PK parameter - Time to Cmax (Tmax)

Measure Description

To be summarized using descriptive statistics

Time Frame

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

Outcome Measure

Number of participants with antidrug antibodies (ADA)

Measure Description

To be summarized using descriptive statistics

Time Frame

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

Outcome Measure

Objective response rate (ORR) as assessed by the investigator

Measure Description

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.

Time Frame

Up to approximately 1 year

Outcome Measure

Complete response (CR) rate as assessed by the investigator

Measure Description

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

Time Frame

Up to approximately 1 year

Outcome Measure

Duration of response (DOR)

Measure Description

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.

Time Frame

Up to approximately 1 year

Number of participants

110

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: None

This information is current as of May 7th 2024.