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History of Changes for Study: NCT04653142
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)
Latest version (submitted May 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 27, 2020 None (earliest Version on record)
2 December 15, 2020 Study Status
3 January 13, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
4 January 25, 2021 Contacts/Locations and Study Status
5 February 8, 2021 Study Status
6 February 22, 2021 Study Status
7 March 8, 2021 Study Status
8 April 6, 2021 Study Status
9 May 4, 2021 Study Status
10 May 18, 2021 IPDSharing and Study Status
11 June 6, 2021 Study Status
12 July 12, 2021 Study Status
13 July 29, 2021 Study Design and Study Status
14 August 9, 2021 Study Status
15 September 6, 2021 Study Status
16 September 20, 2021 Study Status
17 October 4, 2021 Study Status
18 November 2, 2021 Study Status and Contacts/Locations
19 November 18, 2021 Contacts/Locations and Study Status
20 November 30, 2021 Contacts/Locations and Study Status
21 December 13, 2021 Study Status
22 January 12, 2022 Study Status
23 February 8, 2022 Recruitment Status, Study Status and Contacts/Locations
24 February 14, 2022 Eligibility and Study Status
25 February 15, 2022 Study Design and Study Status
26 March 8, 2022 Study Status
27 April 19, 2022 Study Status
28 May 9, 2022 Recruitment Status and Study Status
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Study NCT04653142
Submitted Date:  November 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1443-0004
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: December 14, 2020
Primary Completion: April 5, 2022 [Anticipated]
Study Completion: October 5, 2022 [Anticipated]
First Submitted: November 27, 2020
First Submitted that
Met QC Criteria:
November 27, 2020
First Posted: December 4, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 27, 2020
Last Update Posted: December 4, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Boehringer Ingelheim
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Solid Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
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.
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 42 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BI 765063 (Part A) and BI 765063 + BI 754091 (Part B) Drug: BI 765063
BI 765063
Drug: BI 754091
BI 754091
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Boehringer Ingelheim
Telephone: 1-800-243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No

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: http://trials.boehringer-ingelheim.com/

Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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