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)

NCT05155332
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Phase
Phase 1
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Recruitment status
Suspended
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Participants
190
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Lead sponsor
Boehringer Ingelheim
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Start date
2022-03-28
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Number of sites
27
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Summary
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.
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Short title
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)
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Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Suspended
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Phase
Phase 1
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Study type
Interventional
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Reason stopped
Sponsor decision - temporary enrolment hold as a precautionary measure following a safety event.
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Completion date
2028-10-31
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First posted
2021-12-13
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Registry last updated
2026-08-19
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Primary completion date
2027-12-13
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Start date
2022-03-28
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Participants
190
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Participant count basis
Estimated
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Planned participants
190
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Protocol amendments
8
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Number of sites
27
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Boehringer Ingelheim
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05155332
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ClinicalTrials.gov ID
NCT05155332
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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).

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

    Timeframe: up to 49 months

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

    Timeframe: up to 49 months

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

    Timeframe: up to 49 months

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

    Timeframe: up to 49 months

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

    Timeframe: up to 49 months

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

    Timeframe: up to 49 months

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

    Timeframe: up to 49 months

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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Banner MD Anderson Cancer Center-Gilbert-55251Gilbert, United States
  • University of ArizonaTucson, United States
  • University of California San DiegoLa Jolla, United States
  • Providence St. John's Health CenterSanta Monica, United States
  • University of Colorado DenverAurora, United States
  • Orlando Health Cancer InstituteOrlando, United States
  • M Health Fairview University of Minnesota Medical CenterMinneapolis, United States
  • Morristown Medical CenterMorristown, United States
  • Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, United States
  • The University of Texas MD Anderson Cancer CenterHouston, United States
  • Peninsula Haematology & OncologyFrankston, Australia
  • Medical University of InnsbruckInnsbruck, Austria
  • Salzburg Cancer Research InstituteSalzburg, Austria
  • Universitair Ziekenhuis AntwerpenEdegem, Belgium
  • UZ LeuvenLeuven, Belgium
  • Princess Margaret Cancer CentreToronto, Canada
  • INS BergonieBordeaux, France
  • HOP TimoneMarseille, France
  • CTR Eugène MarquisRennes, France
  • Institut Gustave RoussyVillejuif, France
  • Universitätsklinikum TübingenTübingen, Germany
  • Universitätsklinikum UlmUlm, Germany
  • Istituto Di CandioloCandiolo (TO), Italy
  • Hospital Duran i ReynalsL'Hospitalet de Llobregat, Spain
  • Fundación Jiménez DíazMadrid, Spain

And 2 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2020-003902-30
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)