First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors

Study Identifier:
21820
CT.gov Identifier:
NCT05537740
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-505594-32-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors

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.
  • Solid Tumor
    • 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: Dose escalation - Arm 1A
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  • Drug: Other Names:
  • Drug: Experimental: Dose expansion - Arm 2A
  • Drug: Experimental Drugs
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • Capable of giving signed informed consent.
    • Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit.
    • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
    • Adequate renal and liver function.
    • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.
    • Female participants are eligible if they are not pregnant, not breastfeeding or not a Woman of childbearing potential (WOCBP).
    • Inclusion criterion for the dose-escalation: Individuals with histologically or cytologically confirmed, advanced or metastatic solid tumors.
    • Inclusion criteria for disease-specific combination expansion: Individuals with histologically or cytologically confirmed triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), gastric cancer, melanoma, or head and neck squamous cell carcinoma (HNSCC).
    • Inclusion criterion for the monotherapy-MoA expansion: Individuals with histologically or cytologically confirmed NSCLC, TNBC, HNSCC, or melanoma.
    • Willingness and medical feasibility (as per Investigator assessment) to undergo paired tumor biopsies with a non-significant risk.
    Exclusion criteria
    • A known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • Primary central nervous system malignancy.
    • Major surgery ≤ 28 days before start of study treatment.
    • Any unresolved toxicity of Grade ≥ 2, not otherwise specified in other eligibility criteria, from previous anticancer treatment, except for alopecia and skin pigmentation.
    • Uncontrolled intercurrent illness requiring systemic treatment or solid organ transplant.
    • Known hypersensitivity to study treatment or any drugs similar in structure or class, including severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
    • Any prior immune-related toxicity (Grade 3 or 4) leading to discontinuation of immunotherapy.
    • History of congestive heart failure New York Heart Association (NYHA) >II.
    • Medical history of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically-active pneumonitis/ILD.
    • HIV-infection with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
    • Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
    • History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
    • Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the Investigator affect compliance with study requirements.
    • New brain metastases on screening brain MRI/CT; previously treated brain metastases that are progressive at screening or leptomeningeal disease.
    • Prior therapy with a C-C motif chemokine receptor 8 (CCR8) depleting antibody.
    • Prior allogeneic tissue/solid organ transplant.
    • Radiation therapy to the lung that is > 30 Gy within 6 months before the start of study treatment.
    • Diagnosis of immunodeficiency or current chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).
    • Active autoimmune disease that has required systemic treatment in the past 2 years.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor