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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04653142
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : July 13, 2021
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: BI 765063 Drug: BI 754091 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
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
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
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : December 13, 2021
Estimated Study Completion Date : June 11, 2022

Arm Intervention/treatment
Experimental: BI 765063 (Part A) and BI 765063 + BI 754091 (Part B) Drug: BI 765063
BI 765063

Drug: BI 754091
BI 754091

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of BI 765063, Part A [ Time Frame: up to 3 weeks ]
  2. Maximum Tolerated Dose (MTD) of BI 765063, Part B [ Time Frame: up to 3 weeks ]
  3. Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part A [ Time Frame: up to 3 weeks ]
  4. Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part B [ Time Frame: up to 3 weeks ]

Secondary Outcome Measures :
  1. Number of patients with DLTs, Part A [ Time Frame: 3 weeks per treatment cycle ]
  2. Number of patients with DLTs, Part B [ Time Frame: 3 weeks per treatment cycle ]
  3. Percentage of patients with drug related Adverse Events (AE), Part A [ Time Frame: 3 weeks per treatment cycle ]
  4. Percentage of patients with drug related Adverse Events (AE), Part B [ Time Frame: 3 weeks per treatment cycle ]
  5. Cmax (maximum concentration) for BI 765063, Part A [ Time Frame: up to 3 weeks ]
  6. Cmax (maximum concentration) for BI 765063, Part B [ Time Frame: up to 3 weeks ]
  7. Cmax (maximum concentration) for BI 754091, Part B [ Time Frame: up to 3 weeks ]
  8. AUC0-tz (area under the curve) for BI 765063, Part A [ Time Frame: up to 3 weeks ]
  9. AUC0-tz (area under the curve) for BI 765063, Part B [ Time Frame: up to 3 weeks ]
  10. AUC0-tz (area under the curve) for BI 754091, Part B [ Time Frame: up to 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04653142

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Contact: Boehringer Ingelheim 1-800-243-0127

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National Cancer Center Hospital East Recruiting
Chiba, Kashiwa, Japan, 277-8577
Contact: Toshihiko Doi    +81 4 71331111   
Shikoku Cancer Center Recruiting
Ehime, Matsuyama, Japan, 791-0280
Contact: Kenjiro Aogi    +89 9991111   
Osaka International Cancer Institute Recruiting
Osaka, Osaka, Japan, 541-8567
Contact: Toru Kumagai    +81 6 69451181   
National Cancer Center Hospital Recruiting
Tokyo, Chuo-ku, Japan, 104-0045
Contact: Noboru Yamamoto    +81 3 35422511   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT04653142    
Other Study ID Numbers: 1443-0004
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
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:

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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