First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

Study Identifier
M20-124
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Solid Tumors (General)
  • Study Drug
  • ABBV-CLS-579
  • PD-1 inhibitor
  • VEGFR TKI
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI.

    ABBV-CLS-579 is an investigational drug being developed for the treatment of tumors.

    The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-579 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation, and Part 3 Combination Dose Expansion.

    Part 1, ABBV-CLS-579 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.

    Part 2, ABBV-CLS-579 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors.

    Part 3, ABBV-CLS-579 will be administered at the determined recommended dose in combination with a PD-1 target agent or with a VEGFR TKI in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC).

    Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists or has failed will be enrolled. Participants will receive study treatment until disease progresses or discontinued.

    There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Highlands Oncology Group Springdale
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    Yale University
    New Haven, Connecticut, United States, 06519
    Status
    Not applicable
    Location
    Fort Wayne Medical Oncology and Hematology
    Fort Wayne, Indiana, United States, 46804
    Status
    Not applicable
    Location
    Carolina BioOncology Institute
    Huntersville, North Carolina, United States, 28078
    Status
    Not applicable
    Location
    UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania, United States, 15232
    Status
    Not applicable
    Location
    Hopital Saint-Andre
    Bordeaux, France, 33000
    Status
    Not applicable
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