> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-different-doses-of-bi-1831169-alone-and-in-1352aad3-84c3-490f-8dc4-d3e070fa1135 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) Recruitment status Suspended Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) Participants 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) Start date 2022-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Recruitment status** Suspended Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Reason stopped** Sponsor decision - temporary enrolment hold as a precautionary measure following a safety event. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Dates **Completion date** 2028-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **First posted** 2021-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Primary completion date** 2027-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Start date** 2022-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Size and sites **Participants** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Planned participants** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Identifiers **Registry ID** NCT05155332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **ClinicalTrials.gov ID** NCT05155332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Outcomes ### Primary outcomes 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). ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## References - PubMed 35699077 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/35699077/) Related publication - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers - 2020-003902-30 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05155332) ## Related records ### Drugs (1) - [Toripalimab](https://trialight.com/data/asset/toripalimab-92e6b353-a6c4-4e1e-a99f-559038ba7177.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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