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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04653142
Recruitment Status : Completed
First Posted : December 4, 2020
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE November 27, 2020
First Posted Date  ICMJE December 4, 2020
Last Update Posted Date May 10, 2022
Actual Study Start Date  ICMJE December 15, 2020
Actual Primary Completion Date April 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Maximum Tolerated Dose (MTD) of BI 765063, Part A [ Time Frame: up to 3 weeks ]
  • Maximum Tolerated Dose (MTD) of BI 765063, Part B [ Time Frame: up to 3 weeks ]
  • Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part A [ Time Frame: up to 3 weeks ]
  • Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part B [ Time Frame: up to 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Number of patients with DLTs, Part A [ Time Frame: 3 weeks per treatment cycle ]
  • Number of patients with DLTs, Part B [ Time Frame: 3 weeks per treatment cycle ]
  • Percentage of patients with drug related Adverse Events (AE), Part A [ Time Frame: 3 weeks per treatment cycle ]
  • Percentage of patients with drug related Adverse Events (AE), Part B [ Time Frame: 3 weeks per treatment cycle ]
  • Cmax (maximum concentration) for BI 765063, Part A [ Time Frame: up to 3 weeks ]
  • Cmax (maximum concentration) for BI 765063, Part B [ Time Frame: up to 3 weeks ]
  • Cmax (maximum concentration) for BI 754091, Part B [ Time Frame: up to 3 weeks ]
  • AUC0-tz (area under the curve) for BI 765063, Part A [ Time Frame: up to 3 weeks ]
  • AUC0-tz (area under the curve) for BI 765063, Part B [ Time Frame: up to 3 weeks ]
  • AUC0-tz (area under the curve) for BI 754091, Part B [ Time Frame: up to 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
After the completion of dose escalation with BI 765063 in Part A, Part B will commence and successive dose groups of patients will receive escalating doses of BI 765063 in combination with a fixed dose of BI 754091.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: BI 765063
    BI 765063
  • Drug: BI 754091
    BI 754091
Study Arms  ICMJE Experimental: BI 765063 (Part A) and BI 765063 + BI 754091 (Part B)
Interventions:
  • Drug: BI 765063
  • Drug: BI 754091
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2022)
18
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2020)
42
Actual Study Completion Date  ICMJE April 20, 2022
Actual Primary Completion Date April 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Patients who were born in Japan, and have lived outside Japan <10 years
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04653142
Other Study ID Numbers  ICMJE 1443-0004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Current Responsible Party Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP