Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors

Study Identifier:
1456-0001
CT.gov Identifier:
NCT05155332
EudraCT Identifier:
202000000000
EU Trial (CTIS) Number:
2024-512504-19-00
Study Contact Information:
N/A
Recruiting

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Study Summary

The purpose of the first part is to find the highest dose of BI 1831169 the participants can tolerate. Part 1 also tests whether BI 1831169 can make the tumours shrink.

The purpose of the second part is to find the highest dose of BI 1831169 in combination with ezabenlimab that the participants can tolerate..

The potential synergism of VSV-GP and ezabenlimab will be explored in this first-in-human trial.

To assess the safety, tolerability and early efficacy of VSV-GP given intratumorally (IT), intravenously (IV) or both, as a monotherapy (Part 1) and in combination with ezabenlimab (Part 2) in patients with locally advanced, metastatic or relapsed/refractory solid tumors who previously received or are not candidates for available standard treatment.

To determine the MTD and/or RP2D of VSV-GP as a monotherapy (Part 1) or in combination with the anti-PD-1

antibody ezabenlimab (Part 2), and to assess the safety and tolerability of both regimens when administered IV

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 - 64 Years
    Study Drug
  • Drug: Experimental: Part 1 (Monotherapy): Arm ADrug: BI 1831169
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  • Drug: Experimental: Part 1 (Monotherapy): Arm BDrug: BI 1831169
  • Drug: Experimental: Part 1 (Monotherapy): Arm CDrug: BI 1831169
  • Drug: Experimental: Part 2 (Combination therapy): Arm DDrug: BI 1831169
  • Drug: Drug: anti-PD-1 antibody
  • Drug: Experimental: Part 2 (Combination therapy): Arm EDrug: BI 1831169
  • Drug: Experimental: Part 2 (Combination therapy): Arm FDrug: BI 1831169
  • Drug: Experimental: Part 2 (Combination therapy): Arm GDrug: BI 1831169
  • Drug: SITC 2022:
  • Drug: VSV-GP is given in 21-day cycles, on Days 1 and 4 of Cycle 1, and on Day 1 of Cycles 2-4. Dose finding is guided by the Bayesian Optimal Interval design.
  • Drug: VSV-GP is administered IT, intravenously (IV), or IT+IV as monotherapy (Part 1) or with the anti-PD-1 antibody ezabenlimab (Part 2). VSV-GP is given on Days 1 and 4 of Cycle 1 and Day 1 of Cycles 2-4 (21-day cycles).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., imaging guided procedures) for both biopsies and injections of BI 1831169 Has failed conventional treatment, or for whom no therapy of proven efficacy exists, or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2 Further inclusion criteria apply.
    Exclusion criteria
    • Previous treatment with Vesicular stomatitis virus (VSV)-based agents
    • Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
    • Use of interferon, immunotherapy agents during the treatment phase, or tamoxifen within 30 days prior to or during treatment phase
    • Presence of brain metastases
    • Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
    • Chronic steroid use, regardless of daily dose Further or exclusion criteria apply.

    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
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor