Clinical Trials /

A Study to Find the Best Dose of BI 1387446 Alone or in Combination With BI 754091 in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)

NCT04147234

Description:

Characterize the safety and determine the Maximum tolerated dose (MTD) for BI 1387446 as single agent and for BI 1387446 in combination with BI 754091. Obtain a preliminary efficacy signal.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Find the Best Dose of BI 1387446 Alone or in Combination With BI 754091 in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)
  • Official Title: Phase I, First in Human Trial Evaluating BI 1387446 Alone and in Combination With BI 754091 in Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 1426-0001
  • SECONDARY ID: 2019-001082-32
  • NCT ID: NCT04147234

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
BI 1387446Arm A: BI 1387446
BI 754091Arm B: BI 1387446 in combination with BI 754091

Purpose

Characterize the safety and determine the Maximum tolerated dose (MTD) for BI 1387446 as single agent and for BI 1387446 in combination with BI 754091. Obtain a preliminary efficacy signal.

Trial Arms

NameTypeDescriptionInterventions
Arm A: BI 1387446Experimentalsuperficial lesions
  • BI 1387446
Arm B: BI 1387446 in combination with BI 754091Experimentalsuperficial lesions
  • BI 1387446
  • BI 754091
Arm C: BI 1387446 in combination with BI 754091Experimentaldeep lesions
  • BI 1387446
  • BI 754091

Eligibility Criteria

        Inclusion criteria

          -  Histologically or cytologically confirmed diagnosis of an advanced, unresectable
             and/or metastatic malignant solid tumor and indication for treatment

          -  Patient must have exhausted established treatment options known to prolong survival
             for the malignant disease, or is not eligible for established treatment options.

          -  Medically fit and willing to undergo all mandatory trial procedures.

          -  At least one tumor lesion which is suitable for injection (Screening/initial
             administration), appropriate for the allocated treatment arm, and measurable.

          -  At least 1 discrete lesion, in addition to the lesion proposed for injection, which is
             amenable to biopsy and is not located in the brain, mediastinum or pancreas.

          -  Adequate organ function or bone marrow reserve

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Any investigational or antitumour treatment (including antibodies targeting Programmed
             Cell Death-1 (PD1) - or programmed Death-Ligand 1 (PDL1)) within 4 weeks or 5
             half-life periods (whichever is shorter) prior to the initial administration of BI
             1387446 or BI 754091.

          -  Persistent toxicity from previous treatments (including Immune-related Adverse Events
             (irAEs)) that has not resolved to ≤ Grade 1, except for alopecia, xerostomia, and
             immunotherapy related endocrinopathies which may be included if clinically stable on
             hormone supplements or antidiabetic drugs as per Investigator judgement

          -  History or evidence of active, non-treatment related autoimmune disease, except for
             endocrinopathies which may be included if clinically stable on hormone supplements or
             antidiabetic drugs.

          -  History or evidence of pneumonitis related to prior immunotherapy

          -  Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
             2 weeks prior to the first dose of BI 1387446 or BI 754091.

          -  The tumor at the projected injection site has a high risk for local complications,
             e.g. bleeding related to encasement/infiltration of major blood vessels or contact
             with liver capsule, compression of vital structures in case of swelling of injected
             lesion, in the opinion of the Investigator.

          -  Active infection requiring systemic therapy at the start of treatment in the trial,
             including active viral hepatitis infection or active tuberculosis infection.

          -  Cardiac insufficiency New York Heart Association (NYHA) III or IV

          -  Left ventricular ejection fraction < 50% measured by echocardiography or Multigated
             Acquisition (MUGA) scan

          -  Mean resting corrected QT interval (QTc) >470 msec

          -  Arm C: Patients on therapeutic doses of anticoagulants.

          -  Further exclusion criteria apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD) based on number of Dose-limiting toxicities (DLTs)
Time Frame:3 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response
Time Frame:An average of 1 year
Safety Issue:
Description:
Measure:Best percentage change from baseline in size of injected lesions
Time Frame:An average of 1 year
Safety Issue:
Description:
Measure:Best percentage change from baseline in size of target lesions
Time Frame:An average of 1 year
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

Last Updated

September 8, 2020