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Suspended

NCT Number: NCT05155332

A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.

This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.

Participants visit the site study site regularly. The number of study visits vary based on the study phase 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.

Why the study stopped: Sponsor decision - temporary enrolment hold as a precautionary measure following a safety event.
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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peninsula Haematology & Oncology, Frankston, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
  • At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
  • Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.

Further inclusion criteria apply.

Exclusion criteria

  • Previous treatment with Vesicular stomatitis virus (VSV)-based agents
  • Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
  • Presence of brain metastases
  • Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
  • Chronic steroid use, regardless of daily dose Further exclusion criteria apply.

Treatment and study plan

BI 1831169

Drug

BI 1831169

Anti-PD-1 antibody

Drug

anti-PD-1 antibody

Primary outcomes

  1. Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period

    Time frame: up to 21 days

    Part 1 (Monotherapy).

  2. Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)

    Time frame: up to 49 months

    BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST).

    BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

  3. Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period

    Time frame: up to 21 days

    Part 2 (Combination Therapy).

  4. Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)

    Time frame: up to 49 months

    BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment.

    BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first).

Secondary outcomes

  1. Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period

    Time frame: up to 49 months

  2. Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period

    Time frame: up to 49 months

  3. Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period

    Time frame: up to 49 months

  4. Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period

    Time frame: up to 49 months

  5. Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period

    Time frame: up to 49 months

  6. Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period

    Time frame: up to 49 months

  7. Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period

    Time frame: up to 49 months

  8. Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)

    Time frame: up to 49 months

    DoR is defined as the time from first documented iCR or iPR according to iRECIST until the earliest of disease progression by Investigator's assessment or death among patients with OR.

  9. Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)

    Time frame: up to 49 months

    DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment.

  10. Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)

    Time frame: up to 4 months

    PFS-4 is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment. PFS is assessed by the Investigator using iRECIST.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 13, 2021
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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