Clinical Trials /

A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors)

NCT04653142

Description:

This study is open to Japanese adults with advanced cancer (solid tumors). This is a study in people for whom previous treatment was not successful and for whom no standard therapy exists. The purpose of this study is to find the highest dose of BI 765063 that people can tolerate when taken alone or together with a medicine called BI 754091. BI 765063 and BI 754091 are antibodies that may help the immune system fight cancer (checkpoint inhibitors). Participants get BI 765063 alone or together with BI 754091 as infusion every 3 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors check the health of the participants and note any health problems that could have been caused by BI 765063 or BI 754091.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors)
  • Official Title: An Open Label, Phase I Study of BI 765063 Monotherapy, and Its Combination Therapy With BI 754091, to Characterize Safety, Pharmacokinetics, and Pharmacodynamics in Japanese Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 1443-0004
  • NCT ID: NCT04653142

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
BI 765063BI 765063 (Part A) and BI 765063 + BI 754091 (Part B)
BI 754091BI 765063 (Part A) and BI 765063 + BI 754091 (Part B)

Purpose

This study is open to Japanese adults with advanced cancer (solid tumors). This is a study in people for whom previous treatment was not successful and for whom no standard therapy exists. The purpose of this study is to find the highest dose of BI 765063 that people can tolerate when taken alone or together with a medicine called BI 754091. BI 765063 and BI 754091 are antibodies that may help the immune system fight cancer (checkpoint inhibitors). Participants get BI 765063 alone or together with BI 754091 as infusion every 3 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors check the health of the participants and note any health problems that could have been caused by BI 765063 or BI 754091.

Trial Arms

NameTypeDescriptionInterventions
BI 765063 (Part A) and BI 765063 + BI 754091 (Part B)Experimental
  • BI 765063
  • BI 754091

Eligibility Criteria

        Inclusion Criteria:

          1. Signed and dated the written informed consent form (ICF) prior to any trial-specific
             procedures

          2. Male or female aged ≥ 20 years (no upper limit of age) at the time of ICF signature

          3. Japanese ethnicity, according to the following criteria:

             -- born in Japan, have lived outside of Japan <10 years, and have parents and
             grandparents who are Japanese

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the
             screening visit

          5. Life expectancy of at least 3 months

          6. Patients with at least one Signal Regulatory Protein-alpha (SIRPα) V1 allele will be
             selected, i.e. homozygous V1/V1 or heterozygous V1/V2; SIRPα polymorphism will be
             assessed in blood sampling (patient DNA); V1 allele is understood to include V1 and
             V1-like alleles

          7. Patients with histologically or cytologically documented advanced/metastatic primary
             or recurrent solid tumors who failed or are not eligible to standard therapy

          8. Patients with at least one measurable lesion as per RECIST v1.1 Further inclusion
             criteria apply.

        Exclusion Criteria:

          1. Patients without at least one SIRPα V1 allele, i.e. SIRPα V2/V2 individuals

          2. Previous treatment with study medications in this trial

          3. Patients with symptomatic/active central nervous system (CNS) metastases. Patients
             with previously treated brain metastases are eligible, if there is no evidence of
             progression for at least 28 days before the first study drug administration without
             requirement for treatment with corticosteroids, as ascertained by clinical examination
             and brain imaging magnetic resonance imaging (MRI) or computed tomography (CT)) during
             the screening period

          4. Any tumor location necessitating an urgent therapeutic intervention (e.g., palliative
             care, surgery or radiation therapy, such as spinal cord compression, other compressive
             mass, uncontrolled painful lesion, bone fracture)

          5. Presence of active invasive cancers other than the one treated in this trial within 5
             years prior to screening, except appropriately treated basal cell carcinoma of the
             skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured
             by local treatment

          6. Patients with active autoimmune disease or a documented history of autoimmune disease,
             that requires systemic treatment, i.e. corticosteroids or immunosuppressive drugs,
             except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any
             chronic skin condition that does not require systemic therapy, patients with
             autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
             and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible

          7. Patients who has experienced severe infusion related reaction (IRR) to monoclonal
             antibody (mAb) (Grade ≥ 3 NCI CTCAE v5.0)

          8. Patients removed from previous anti-PD-1 or anti-PD-L1 therapy because of a severe, or
             life-threatening immune related adverse event (irAE) (Grade ≥ 3 NCI CTCAE v5.0)
             Further exclusion criteria apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of BI 765063, Part A
Time Frame:up to 3 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patients with DLTs, Part A
Time Frame:3 weeks per treatment cycle
Safety Issue:
Description:
Measure:Number of patients with DLTs, Part B
Time Frame:3 weeks per treatment cycle
Safety Issue:
Description:
Measure:Percentage of patients with drug related Adverse Events (AE), Part A
Time Frame:3 weeks per treatment cycle
Safety Issue:
Description:
Measure:Percentage of patients with drug related Adverse Events (AE), Part B
Time Frame:3 weeks per treatment cycle
Safety Issue:
Description:
Measure:Cmax (maximum concentration) for BI 765063, Part A
Time Frame:up to 3 weeks
Safety Issue:
Description:
Measure:Cmax (maximum concentration) for BI 765063, Part B
Time Frame:up to 3 weeks
Safety Issue:
Description:
Measure:Cmax (maximum concentration) for BI 754091, Part B
Time Frame:up to 3 weeks
Safety Issue:
Description:
Measure:AUC0-tz (area under the curve) for BI 765063, Part A
Time Frame:up to 3 weeks
Safety Issue:
Description:
Measure:AUC0-tz (area under the curve) for BI 765063, Part B
Time Frame:up to 3 weeks
Safety Issue:
Description:
Measure:AUC0-tz (area under the curve) for BI 754091, Part B
Time Frame:up to 3 weeks
Safety Issue:
Description:

Details

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

Last Updated

May 19, 2021