An Open Label, Phase I Dose-finding Study of BI 754111 in Combination With BI 754091 in Patients With Advanced Solid Cancers Followed by Expansion Cohorts at the Selected Dose of the Combination in Patients With Non-small Cell Lung Cancer and Other Solid Tumors

Who is this study for? Patients with Non-Small Cell Lung Cancer
What treatments are being studied? BI 754111+BI 754091
Status: Completed
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer. Such medicines are called immune checkpoint inhibitors. The study has two parts. In the first part, doctors want to find out the highest dose of 2 medicines that people with solid tumors can tolerate. This dose is then used for the second part of the study. In the second part, the combination of the two medicines is tested in patients with non-small cell lung cancer and other types of solid cancer. These patients had gotten treatment with anti-PD-1 or anti-PD-L1 medicines but their tumors have come back. The doctors check whether the combination of BI 754111 and BI 754091 makes tumors shrink. Both medicines are given as an infusion into the vein every 3 weeks. If there is benefit for the patients and if they can tolerate it, the treatment is given for maximum of 1 year. During the entire study doctors will regularly check the health of the patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated, written Informed consent form (ICF) prior to any trial-specific procedures, sampling, or analyses

• Patients ≥18 years of age at the time of signature of the ICF

• Part I (dose escalation):

⁃ -Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)

⁃ For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.

⁃ Must have measurable lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

⁃ Previous treatment with an anti-programmed cell death 1 (receptor) (PD-1) monoclonal antibody (mAb) is allowed as long as the last administration of the anti-PD-1 mAb on the previous treatment is a minimum of 60 days prior to starting treatment in this trial.

• Part II (dose expansion):

‣ Patients must have measurable disease per RECIST v1.1 criteria, must have at least 1 tumour lesion amenable to biopsy, and must be medically fit and willing to undergo a biopsy before first treatment (if adequate archival tissue is not available) and, unless clinically contraindicated, after 6 weeks on therapy.

⁃ Dose Expansion Cohorts: Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours of one of the following types:

• Second and 3rd line Non-small cell lung cancer (NSCLC) patients:

‣ Must have progressed on anti-PD-1 or anti-programmed cell death ligand 1 (PD-L1) treatment after having achieved radiologically confirmed benefit (minimum of stable disease)

⁃ Must have had a minimum duration of benefit of 4 months and minimum treatment duration of 2 months on the previous anti- PD-1 or anti-PD-L1 treatment without experiencing disease progression during that period.

⁃ The anti-PD-1- or anti-PD-L1-containing treatment must have been the latest treatment regimen prior to enrolling in this trial

⁃ Must be within \>4 and \<12 weeks since the latest treatment and their first dose in this trial. Patients who have had anti-PD-1 or anti-PD-L1 monotherapy as their first-line NSCLC treatment regimen must have a PD-L1 expression level of ≥1% at baseline (local validated testing).

∙ Anti-PD-1 or anti-PD-L1 treatment-naïve patients with microsatellite stable Metastatic colorectal Cancer (mCRC):

‣ Patients must have had ≥ 1 line treatment

⁃ Must have microsatellite stable disease (identified using any validated test)

⁃ Must be anti-PD-1 and anti-PD-L1 treatment naïve

∙ Anti-PD-1 or anti-PD-L1 pretreated patients with any high Tumour mutational burden (TMB) (≥10 mutations/Mb) and/or Microsatellite instability high (MSI-H) and/or DNA MMRd solid tumours

‣ Patients must have high TMB (≥ 10 mutations/Mb) and/or MSI-H and/or DNA mismatch repair deficient (MMRd) (measured using any validated test).

⁃ Patients must have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.

∙ 1st-line squamous or non-squamous NSCLC patients:

‣ Patients must be treatment naïve

⁃ Must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type (only applicable to patients with non-squamous NSCLC)

⁃ Regardless of PD-L1 expression level. However, the number of patients with high level of PD-L1 expression (≥50% PD-L1) will be limited to a maximum of 10 patients

• Eastern Cooperative Oncology Group (ECOG, R01-0787) score: 0 to 1

• 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) and men able to father a child must be ready 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. A list of contraception methods meeting these criteria is provided in the patient information.

Locations
United States
Florida
University of Miami
Miami
Florida Cancer Specialists
Sarasota
New Jersey
John Theurer Cancer Center
Hackensack
Oklahoma
Stephenson Cancer Center
Oklahoma City
Tennessee
Tennessee Oncology, PLLC
Nashville
Wisconsin
Froedtert and The Medical College of Wisconsin
Milwaukee
Other Locations
Canada
Cross Cancer Institute (University of Alberta)
Edmonton
Princess Margaret Cancer Centre
Toronto
Poland
BioVirtus Research Site Sp. z o.o.
Józefów
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
Warsaw
Spain
Hospital Universitari Dexeus
Barcelona
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Politècnic La Fe
Valencia
United Kingdom
Sarah Cannon Research Institute
London
Time Frame
Start Date: 2017-06-13
Completion Date: 2023-06-06
Participants
Target number of participants: 172
Treatments
Experimental: Part I - Dose--Escalation
Experimental: Part II - Dose-Expansion
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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