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)

• ClinicalTrials.gov Identifier: NCT04653142
• Recruitment Status: Completed
• First Posted: December 4, 2020
• Last Update Posted: May 10, 2022
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: November 27, 2020
• First Posted Date: December 4, 2020
• Last Update Posted Date: May 10, 2022
• Actual Study Start Date: December 15, 2020
• Actual Primary Completion Date: April 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 1

Study Design

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: Solid Tumors

Intervention

• Drug: BI 765063
  BI 765063
• Drug: BI 754091
  BI 754091

Study Arms

Experimental: BI 765063 (Part A) and BI 765063 + BI 754091 (Part B)

Interventions:

• Drug: BI 765063
• Drug: BI 754091

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 15, 2022): 18
• Original Estimated Enrollment (submitted: November 27, 2020): 42
• Actual Study Completion Date: April 20, 2022
• Actual Primary Completion Date: April 20, 2022 (Final data collection date for primary outcome measure)

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. 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

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04653142
• Other Study ID Numbers: 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

• 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: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boehringer Ingelheim
• Verification Date: May 2022