An open-label, Phase II, platform trial evaluating safety and efficacy of multiple BI 754091 anti-PD-1 based combination regimens in PD-(L)1 naïve and PD-(L)1 pretreated patient populations with advanced and/or metastatic solid tumours who have had at least one line of systemic therapy

Study of Investigational Medications in Advanced Solid Tumors

Recruiting
18 years - 100 years
All
1 Location

Brief description of study.

This study is being done in subjects with advanced and/or metastatic solid tumors. The treatment-specific Module A portion of the study will test the combination of the investigational drugs BI 754091 and BI 754111.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Solid Tumor
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patient must agree to a pre-treatment biopsy (if archival tissue is not available) and on-treatment tumour biopsy.
  • Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be willing and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial participation and for at least 6 months after the last administration of trial medication.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1904395200 (1381-0009)

This study investigates the effects of investigational medications in individuals with advanced or metastatic solid tumors. Advanced or metastatic solid tumors are cancers that have spread from their original location to other parts of the body. The study will examine the combination of two investigational drugs to assess their potential impact on these types of tumors.

Participants in the study will undergo procedures such as pre-treatment and on-treatment tumor biopsies. A biopsy is a medical test involving the removal of cells or tissues for examination. These procedures are essential for understanding how the investigational drugs interact with the tumor cells.

  • Who can participate: Adults with advanced or metastatic solid tumors who agree to undergo biopsies are eligible. Participants must use effective birth control during the trial and for six months after.
  • Study details: Participants will receive a combination of investigational medications. They will need to have biopsies before and during the treatment to assess the effects of the medications.

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