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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-Glucuronide TOP1 Inhibitor Conjugate

PF-08046044, SGN-35C is an investigational compound. Its safety and efficacy have not been established

A Phase 1, Open-label Study to Evaluate SGN-35C in Adults With Advanced Malignancies

Phase 1

NCT06254495

Active enrolling

Globe

Locations

United States, Denmark, Italy

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Study design
Participant Group/Arm

EXPERIMENTAL: SGN-35C

SGN-35C Monotherapy

Intervention/Treatment

DRUG: SGN-35C

Given into the vein (IV; intravenously)
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • Tumor type
  • For dose escalation and dose optimization (Parts A and B):
    • Participants with a histologically confirmed lymphoid neoplasm who in the judgement of the investigator have no appropriate standard therapy available at the time of enrollment and are a candidate for SGN- 35C treatment. Eligible subtypes and treatment status are as follows:
  • For dose escalation and dose optimization (Parts A and B):
    • Participants with PTCL and DLBCL must have a detectable cluster of differentiation 30 (CD30) expression level (≥1%) in tumor tissue from the most recent biopsy obtained at or after relapse by local testin
  • For dose expansion (Part C):
    • Participants are eligible irrespective of CD30 expression on tumor tissue; however, participants must provide tumor tissue for evaluation of CD30 expression from the most recent biopsy obtained at or after relapse.
    • Participants with cHL, PTCL, sALCL, and DLBCL: Eligible subtypes are the same as defined in Parts A and B
    • If activated, the biology cohort may enroll the populations included in Parts A, B, and
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
  • Fluorodeoxyglucose positron emission tomography (FDG-PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral computed tomography \[CT\] preferred)
Exclusion criteria
  • Previous exposure to any antibody-drug conjugates (ADCs) with camptothecin-based payload.
  • History of another malignancy within 3 years before the first dose of study drug, 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 the first dose of SGN-35C.
  • 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 (GVHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GVH
  • History of clinically significant GI bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of trial treatment.
    • Key dates
    Study start date
    • May 2024
    Estimated Study Completion Date
    • August 2028
    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

    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

    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

    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

    Time at which the maximum concentration occurs (Tmax)

    Measure Description

    To be summarized using descriptive statistics

    Time Frame

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

    Outcome Measure

    Apparent terminal half-life (t1/2)

    Measure Description

    To be summarized using descriptive statistics

    Time Frame

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

    Outcome Measure

    Trough concentration (Ctrough)

    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 participant is determined to have an objective response if, based on Lugano criteria (Cheson 2014), 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

    CR rate as assessed by the investigator

    Measure Description

    CR rate is defined as the proportion of participants 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 Lugano criteria (Cheson 2014) 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

    170

    Collaborators and investigators

    Sponsor: Seagen Inc.

    Collaborator: None

    This information is current as of November 13th 2024.

    Contact Us
    Close

    For more information, call or email the Pfizer Clinical Trial Contact Center:

    1-800-887-7002 Email us

    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. NCT06254495