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

  • NCT05155332
  • PHASE1
  • INTERVENTIONAL

Last updated: 2024-08-16

Purpose of  Trial

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.


This study is for people with

Solid Tumors


Interventions being studied

BI 1831169

anti-PD-1 antibody

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of an advanced, metastatic or relapsed/refractory solid tumor

* 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., imaging guided procedures) for both biopsies and 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. 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

* Use of interferon, immunotherapy agents during the treatment phase, or tamoxifen within 30 days prior to or during treatment phase

* 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 or exclusion criteria apply.

Register to Save
ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

6 Locations
Santa Monica

Providence St. John's Health Center


California, 90404, United States
Aurora

University of Colorado Denver


Colorado, 80045, United States
Minneapolis

M Health Fairview University of Minnesota Medical Center


Minnesota, 55455, United States
Morristown

Morristown Medical Center


New Jersey, 07960, United States
Winston-Salem

Atrium Health Wake Forest Baptist Comprehensive Cancer Center


North Carolina, 27157, United States
Houston

The University of Texas MD Anderson Cancer Center


Texas, 77030, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

Back to Results New Search