An Open-Label Phase I Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants With Advanced Malignancies.

Study Identifier:
C5911001
CT.gov Identifier:
NCT06870487
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-517756-35-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

The purpose of this study is to learn about the effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. The effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body)

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Lymphoma
  • Head & Neck
  • Melanoma
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: PF-08046032 Monotherapy Dose Escalation
    • Read More
  • Drug: Experimental: PF-08046032 + Sasanlimab Combination Safety Evaluation
  • Drug: Drug: Sasanlimab
  • Drug: Experimental: PF-08046032 + Sasanlimab Combination Expansion Cohort
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Histological or cytological diagnosis of metastatic or unresectable malignancy:
    • Part A1: Participants with lymphomas (cHL, PTCL, large B-cell lymphoma) who have progressed on/after standard therapies
    • Part A2: Participants with solid tumors (NSCLC, HNSCC, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available
    • Part B: Participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy
    • Part C: Participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor
    • Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors
    • Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment
    • ECOG Performance Status score 0 or 1
    Exclusion criteria
    • Ongoing peripheral neuropathy
    • History of significant immune-mediated adverse event considered related to prior immune-modulatory therapy
    • Known or suspected active autoimmune disease

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Lymphoma
    Head & Neck
    Melanoma
    Non-Small Cell Lung Cancer