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

Geo Regions

Category

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

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Locations

United States, Spain

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Study design

Participant Group/Arm

EXPERIMENTAL: SGN-35T

SGN-35T monotherapy

Intervention/Treatment

DRUG: SGN-35T

Given into the vein (IV; intravenously)
Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
  • Disease indication
    • For dose escalation and dose optimization (Part A and Part B):
  • Disease indication
    • For dose expansion (Part C)
  • 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

    Measure Description

    Time Frame

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

    Outcome Measure

    Number of participants with dose modifications due to AEs

    Measure Description

    Time Frame

    Up to approximately 1 year

    Outcome Measure

    Number of participants with dose-limiting toxicities (DLTs)

    Measure Description

    Time Frame

    Up to 21 days

    Outcome Measure

    Number of participants with DLTs by dose level

    Measure Description

    Time Frame

    Up to 21 days

    Primary Outcome Measures table for Clinical Trial
    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

    Secondary Outcome Measures table for Clinical Trial

    Number of participants

    110

    Collaborators and investigators

    Sponsor: Seagen Inc.

    Collaborator: None

    This information is current as of August 28th 2024.
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    For more information, call or email the Pfizer Clinical Trial Contact Center:

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    When calling, please reference this study number:

    More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06120504