Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours.
The aim of this study is to assess the efficacy of BI 754091 in combination with other checkpoint inhibitors or anticancer medications in diverse tumour type cohorts.
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
You can join if…
Open to people ages 18 years and up
- Provision of signed and dated, written Master informed consent form (ICF) prior to any trial-specific procedures, sampling, or analyses.
- Patient ≥18 years of age at the time of signature of the ICF.
- Eastern Cooperative Oncology Group (ECOG) score: 0 to 1.
- Patient must agree to a pre-treatment biopsy (if archival tissue is not available) and on-treatment tumour biopsy.
- Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement.
- 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.
-Histologically confirmed diagnosis of one of the following cohorts:
- Cohort 1 GEC - Locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro oesophageal adenocarcinoma (GEC) (defined as primary tumour localisation below the gastro oesophageal junction (GEJ) with prior anti-PD-1 or anti-PD-L1 based treated tumour.
- Cohort 2 Patients with secondary resistance to anti-PD-1 or anti-PD-L1 based therapy: Any advanced or metastatic solid tumour with previously anti-PD-1 or anti-PD-L1 based treatment who progressed after achieving benefit
- Cohort 3 Patients with primary resistance to anti-PD-1 or anti-PD-L1 based therapy: Select advanced or metastatic solid tumour types with previous anti-PD- 1/PD-L1 based treated tumour without achieving benefit.
- All patients must have measurable lesions according to RECIST v1.1
- Patient must agree to pre- and on-treatment tumour biopsies. If archived tumour tissue is available from the last treatment failure, sections may be supplied instead of a pre-treatment biopsy.
You CAN'T join if...
- Any investigational treatment anti-tumour treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
- A maximum of one anti-PD-(L)1-based treatment regimen prior to entering study
- Major surgery ('major' according to the Investigator's assessment) performed within 12 weeks prior to first trial treatment or planned within 12 months after screening, e.g., hip replacement.
- Known history of severe hypersensitivity reactions to other mAbs or known hypersensitivity to the trial drugs or their excipients.
- Known presence of symptomatic central nervous system (CNS) metastases, unless asymptomatic and off corticosteroids and/or anticonvulsant therapy for at least 2 weeks prior to start of treatment.
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
- Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy, or a patient removed from previous anti-PD-1 or anti-PD-L1 therapy because of a severe immune-related adverse event (irAE).
- Previous treatment with an anti-LAG-3 agent
- The use of systemic steroids
- Autoimmune disease
- University of California San Diego
accepting new patients
La Jolla California 92037 United States
- accepting new patients
- Start Date
- Completion Date
- Boehringer Ingelheim
- Phase 2
- Study Type
- Last Updated
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