A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Study Identifier:
XmAb819-01
CT.gov Identifier:
NCT05433142
EudraCT Identifier:
2024-513619-28-00
EU Trial (CTIS) Number:
2024-513619-28-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate XmAb30819 in patients with renal cell carcinoma. To evaluate the safety and tolerability of intravenous (IV) administration of XmAb®819 in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and active dose. This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. To evaluate XmAb819 in patients with advanced ccRCC.

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.
  • Renal
    • 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:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator or radiology department Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies ECOG performance status of 0 or 1 All subjects in Part B, dose expansion, must have a tumor lesion that can be biopsied and must agree to a fresh biopsy during screening and second biopsy to be collected between Days 1 to 8 of Cycle 2 All subjects in Part A, dose escalation, must have adequate tumor sample (slides or archival FFPE blocks). Expected are subjects who consent to having a fresh tumor biopsy to provide a fresh tumor sample instead of the archival tumor sample
    Exclusion criteria
    • Prior treatment with an investigational anti-ENPP3/CD203c therapy
    • History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
    • Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
    • Failure to recover from any clinically significant toxicity related to previous anticancer treatment
    • Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
    • Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
    • Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
    • Have a known additional malignancy that is progressing or has required active treatment within 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
    Jesus Garcia-Donas
    Status
    Recruiting
    Condition(s) Treated at Site
    Renal