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Solid TumorsPhase 1NCT07176975

A Study to Test How Well Different Doses of BI 1831169 in Combination With an Anti-PD1 Antibody Are Tolerated in Japanese People With Different Advanced Cancers

A Phase 1 study testing BI 1831169 and nivolumab in people with Solid Tumors, run by Boehringer Ingelheim at 1 site in Japan.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
BI 1831169 and nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteJapan
Study dates
3 Aug 2027to 22 May 2029
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumours
  • Has at least 1 accessible lesion with a minimum lesion diameter (≥1 cm) for injection of BI 1831169. Lesions must either be easily accessible, or, if not easily accessible, patients must be willing to undergo repeat procedures for injections of BI 1831169.
  • Has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patients must have exhausted available treatment options known to prolong survival for their disease.
  • Medically fit and willing to undergo all mandatory trial procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy of at least ≥3 months after the start of the treatment, according to the investigator's judgement
  • Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values:
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  • Absolute neutrophil count ≥1.5x10^9/L (≥1.5x10^3/μL, ≥1500/mm^3) without white blood cell growth factor support within 4 weeks of start of trial treatment; platelet count ≥100·10^9/L (≥100·10^3/μL, ≥100·10^3/mm^3), without platelet transfusion within 2 weeks of start of trial treatment
  • Haemoglobin ≥90 g/L (≥9.0 g/dL, ≥5.6 mmol/L)
  • Creatinine ≤1.5x upper limit of normal (ULN)
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3x ULN if no demonstrable liver metastases, or otherwise ≤5x ULN if transaminase elevation is attributable to liver metastases
  • Total bilirubin ≤1.5x ULN, except for patients with Gilbert's syndrome: total bilirubin ≤3.0x ULN or direct bilirubin ≤1.5x ULN
  • Partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) <1.5x ULN unless on a stable dose of an anticoagulant and no unexplained elevation of international normalised ratio (INR)
  • All toxicities related to previous anti-cancer therapies (including immune related adverse event (irAEs)) have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1 prior to the start of trial treatment (except for alopecia, xerostomia, and immunotherapy related endocrinopathies which may be included if clinically stable on hormone supplements or antidiabetic drugs as per investigator judgement) and others per investigator judgement.
  • Male or female, ≥18 years of age at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.

Who cannot join

  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of trial treatment
  • Radiotherapy within 4 weeks prior to the start of trial treatment, except in case of a brief course of palliative radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture) which can then be completed within 2 weeks prior to start of trial treatment. Note: No radiation must have been given to any lesions planned to be injected within 6 months of start of treatment.
  • Presence of brain metastases unless patient has completed brain radiotherapy and is asymptomatic. Symptomatic brain metastases, untreated malignant brain tumours and/or carcinomatous meningitis are excluded.
  • Presence of other active invasive cancers other than the one to be treated in this trial within 3 years prior to screening, except for appropriately treated basal-cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment
  • Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade ≤1, except for alopecia, xerostomia, CTCAE Grade 2 neuropathy, asthenia/fatigue, or Grade 2 endocrinopathies controlled by replacement therapy
  • Active or chronic hepatitis B or C infection, e.g. Hepatitis B surface antigen (HBsAg) positive or Hepatitis C antibody (anti-HCV) positive (except if hepatitis C virus (HCV)-ribonucleic acid (RNA) negative)
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  • Patients with history of human immunodeficiency virus (HIV) infection who meet 1 or more of the following criteria:
  • cluster of differentiation 4 (CD4+) count <350 cells/μL
  • Viral load >400 copies/mL (local lab assessment)
  • Not receiving antiretroviral therapy
  • Receiving established antiretroviral therapy for less than 4 weeks prior to the start of study treatment
  • History of AIDS-defining opportunistic infections within 12 months prior to start of study treatment Patients with a history of HIV who do not meet any of the criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist or an HIV/Infectious Diseases specialist must be consulted prior to inclusion.
  • Any severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality as per investigator's judgement that may increase the risk associated with trial participation or investigational medicinal product (IMP) administration, including ongoing or active infection requiring systemic antibiotics Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

Other trials in Japan

About this study

Official title: Phase I Open-label, Dose Escalation and Expansion Trial of BI 1831169 in Combination With an Anti-PD1 mAb in Japanese Patients With Advanced/Metastatic Solid Tumours

This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist.

The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people can tolerate when taken together with an anti-PD1 antibody. The anti-PD1 antibody is already used to treat different cancers. Participants receive BI 1831169 together with an anti-PD1 antibody, which is given as an infusion into a vein for up to 1 year.

Participants visit the study site regularly. The number of site visits vary based on the study part and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

Conditions
Solid Tumors
Being tested
BI 1831169, nivolumab

What participants receive

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

  • BI 1831169Drug

    BI 1831169

  • nivolumabDrug

    nivolumab

Study groups in NCT07176975
Study groupRoleWhat they receive
Dose escalation part: BI 1831169 dose level 1 + anti-PD-1 antibodyExperimentalNot described
Receives: Drug: BI 1831169; Drug: nivolumab
Dose escalation part: BI 1831169 dose level 2 + anti-PD-1 antibodyExperimentalNot described
Receives: Drug: BI 1831169; Drug: nivolumab
Dose escalation part: BI 1831169 dose level 3 + anti-PD-1 antibodyExperimentalNot described
Receives: Drug: BI 1831169; Drug: nivolumab
Dose escalation part: BI 1831169 dose level 4 + anti-PD-1 antibodyExperimentalNot described
Receives: Drug: BI 1831169; Drug: nivolumab
Dose expansion part: BI 1831169 + anti-PD-1 antibodyExperimentalNot described
Receives: Drug: BI 1831169; Drug: nivolumab

What is being measured

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

  1. Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period

    Measured: up to 6 weeks

Secondary outcomes (2)

  1. Occurrence of dose limiting toxicities (DLTs) during the on-treatment period.

    Measured: up to 12 months

  2. Occurrence of adverse events (AEs) during the on-treatment period

    Measured: up to 12 months

Timeline

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

  1. First posted16 Sep 2025
  2. Study start3 Aug 2027 (estimated)
  3. Primary completion19 Dec 2028 (estimated)
  4. Study completion22 May 2029 (estimated)

Why it stopped: company decision

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176975
Sponsor's protocol ID
1456-0004
Other IDs
U1111-1294-3482
Status last verified
Jul 2026
First submitted
15 Sep 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1831169 and nivolumab in people with Solid Tumors, run by Boehringer Ingelheim at 1 site 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 14 inclusion and 13 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: paused, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period (time frame: up to 6 weeks). 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 NCT07176975.

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 7 Jul 2026.

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