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

Other or Multiple Cancer Types

PD-L1-directed Antibody Drug Conjugate

PF-08046054, SGN-PDL1V is an investigational compound. Its safety and efficacy have not been established

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Phase 1
NCT05208762

Active enrolling

Globe
Locations

United States, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom

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Study design

Participant Group/Arm

EXPERIMENTAL: PF-08046054 Monotherapy

PF-08046054 monotherapy

Intervention/Treatment

DRUG: PF-08046054

Given into the vein (IV; intravenously)
Participant Group/Arm

EXPERIMENTAL: PF-08046054 Combination Therapy

PF-08046054 + pembrolizumab

Intervention/Treatment

DRUG: PF-08046054

Given into the vein (IV; intravenously)

DRUG: pembrolizumab

200 mg once every 3 weeks given into the vein (IV; intravenously)
Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
  • Parts A and B:
    • Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
  • Parts A and B:
    • Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
    • Participants must have PD-L1 expression based on historical testi
  • Part C:
    • Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
  • Part C:
    • Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \<1 by CPS or TPS based on historical testi
  • Part D and Part E:
    • Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
    • Participants must have PD-L1 expression based on historical testing
    • Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
    • Participants with HNSCC; PD--L1 expression ≥1 by C
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Measurable disease per RECIST v1.1 at baseline
Exclusion criteria
  • History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
  • Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:
    • Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
    • Have no new or enlarging brain metastases
    • And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatme
  • Lepto-meningeal disease
  • Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
  • Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
  • Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. There are additional inclusion criteria. The study center will determine if criteria for participations are met.

    • Key dates

    Study start date
    • October 2022
    Estimated primary completion date
    • December 2026

    Key endpoints

    Primary Outcome Measures
    Outcome Measure

    Number of participants with adverse events (AEs)

    Measure Description

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

    Time Frame

    Through approximately 90 days after last study treatment; up to 3 years

    Outcome Measure

    Number of participants with laboratory abnormalities

    Measure Description

    Time Frame

    Through approximately 90 days after last study treatment; up to 3 years

    Outcome Measure

    Number of participants with dose-limiting toxicities (DLTs)

    Measure Description

    Time Frame

    Through the first cycle of study treatment; approximately 1 month

    Outcome Measure

    Number of participants with DLTs by dose level

    Measure Description

    Time Frame

    Through the first cycle of study treatment; approximately 1 month

    Primary Outcome Measures table for Clinical Trial
    Secondary Outcome Measures:
    Outcome Measure

    Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment

    Measure Description

    The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.

    Time Frame

    Up to approximately 3 years

    Outcome Measure

    Duration of objective response (DOR) per RECIST v1.1 by investigator assessment

    Measure Description

    The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.

    Time Frame

    Up to approximately 3 years

    Outcome Measure

    Progression-free survival (PFS) per RECIST v1.1 by investigator assessment

    Measure Description

    The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause.

    Time Frame

    Up to approximately 3 years

    Outcome Measure

    Overall survival (OS)

    Measure Description

    The time from the start of study treatment to death due to any cause.

    Time Frame

    Up to approximately 3 years

    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; up to approximately 3 years

    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; up to approximately 3 years

    Outcome Measure

    PK parameter - Trough concentration (Ctrough)

    Measure Description

    To be summarized using descriptive statistics

    Time Frame

    Through 30-37 days after last study treatment; up to approximately 3 years

    Outcome Measure

    Incidence of anti-drug antibodies (ADAs)

    Measure Description

    To be summarized using descriptive statistics

    Time Frame

    Through 30-37 days after last study treatment; up to approximately 3 years

    Secondary Outcome Measures table for Clinical Trial

    Number of participants

    438

    Collaborators and investigators

    Sponsor: Seagen Inc.

    Collaborator: None

    This information is current as of August 19th 2024.
    Contact Us
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    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. NCT05208762