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Phase 2 study of intratumoral CMP-001 in combination with an intravenous PD-1-blocking antibody administered to participants with certain types of advanced or metatastic cancer.

A Multicenter, Open-label, Phase 2 Study of Intratumoral CMP-001 in Combination With an Intravenous PD-1-Blocking Antibody in Subjects With Selected Types of Advanced or Metastatic Cancer

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Grofsik, Kiera; Frankos, Marie

  • IRB No: W21.125.08

    Protocol Abbrev: CMP-001-009

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: CMP-001-009

    Treatment: CMP-001 Cemiplimab-rwlc

    Therapies Involved: Oncology: 2nd line

    ClinicalTrials.gov ID: NCT04916002

  • Objective

    The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with a programmed cell death protein (PD-1)-blocking antibody in subjects with certain types of advanced or metatastic cancer.

    The secondary objectives are to:

    To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with a PD-1-blocking antibody in study subjects.
    To evaluate the efficacy of CMP-001 in combination with a PD-1-blocking antibody in study subjects.
    Participants will continue to receive treatment of CMP-001 in combination with a PD-1-blocking antibody according to the treatment schedule until a reason for treatment discontinuation is reached.

  • Key Eligibility

    Inclusion Criteria: Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible.

    1.Histopathologically-confirmed diagnosis of cancer that is metastatic or unresectable at Screening.
    2.Measurable disease, as defined by RECIST v1.1 and all of the following:
    At least 1 accessible lesion amenable to repeated IT injection.
    A previously irradiated lesion may be used as a target lesion if subsequent disease progression in that lesion was documented.
    3.Able to provide tissue from a core or excisional/incisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable if no intervening therapy was received.
    4.Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1)
    5.Age ≥ 18 years at time of consent.
    6.Eastern Cooperative Oncology Group Performance Status of 0 to 1 at Screening.
    7.Capable of understanding and complying with protocol requirements.
    8.Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 150 days after last dose of study treatment.
    9.Able and willing to provide written informed consent and to follow study instructions.