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Solid TumorsPhase 1NCT04653142

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)

A Phase 1 study testing BI 765063 and BI 754091 in people with Solid Tumors, run by Boehringer Ingelheim at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumors
What is being tested?
BI 765063 and BI 754091
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesJapan
Study dates
15 Dec 2020to 20 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated the written informed consent form (ICF) prior to any trial-specific procedures
  • Male or female aged ≥ 20 years (no upper limit of age) at the time of ICF signature
  • Patients who were born in Japan, and have lived outside Japan <10 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the screening visit
  • Life expectancy of at least 3 months
  • 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
  • Patients with histologically or cytologically documented advanced/metastatic primary or recurrent solid tumors who failed or are not eligible to standard therapy
  • Patients with at least one measurable lesion as per RECIST v1.1 Further inclusion criteria apply.

Who cannot join

  • Patients without at least one SIRPα V1 allele, i.e. SIRPα V2/V2 individuals
  • Previous treatment with study medications in this trial
  • 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
  • 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)
  • 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
  • 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
  • Patients who has experienced severe infusion related reaction (IRR) to monoclonal antibody (mAb) (Grade ≥ 3 NCI CTCAE v5.0)
  • 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.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • Shikoku Cancer Center

    Ehime, Matsuyama, 791-0280

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

Other trials in Japan

About this study

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

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.

Conditions
Solid Tumors
Being tested
BI 765063, BI 754091

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 765063Drug

    BI 765063

  • BI 754091Drug

    BI 754091

Study groups in NCT04653142
Study groupRoleWhat they receive
BI 765063 (Part A) and BI 765063 + BI 754091 (Part B)ExperimentalNot described
Receives: Drug: BI 765063; Drug: BI 754091

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of BI 765063, Part A

    Measured: up to 3 weeks

  2. Maximum Tolerated Dose (MTD) of BI 765063, Part B

    Measured: up to 3 weeks

  3. Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part A

    Measured: up to 3 weeks

  4. Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part B

    Measured: up to 3 weeks

Secondary outcomes (10)

  1. Number of patients with DLTs, Part A

    Measured: 3 weeks per treatment cycle

  2. Number of patients with DLTs, Part B

    Measured: 3 weeks per treatment cycle

  3. Percentage of patients with drug related Adverse Events (AE), Part A

    Measured: 3 weeks per treatment cycle

  4. Percentage of patients with drug related Adverse Events (AE), Part B

    Measured: 3 weeks per treatment cycle

  5. Cmax (maximum concentration) for BI 765063, Part A

    Measured: up to 3 weeks

  6. Cmax (maximum concentration) for BI 765063, Part B

    Measured: up to 3 weeks

  7. Cmax (maximum concentration) for BI 754091, Part B

    Measured: up to 3 weeks

  8. AUC0-tz (area under the curve) for BI 765063, Part A

    Measured: up to 3 weeks

  9. AUC0-tz (area under the curve) for BI 765063, Part B

    Measured: up to 3 weeks

  10. AUC0-tz (area under the curve) for BI 754091, Part B

    Measured: up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion20 Apr 2022
  4. Study completion20 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
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)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653142
Sponsor's protocol ID
1443-0004
Status last verified
May 2022
First submitted
27 Nov 2020
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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: https://www.mystudywindow.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 765063 and BI 754091 in people with Solid Tumors, run by Boehringer Ingelheim at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of BI 765063, Part A (time frame: up to 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04653142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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