Thoracic Cancer SCRI REFMAL485

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

Eligibility Criteria:

  • 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 Informed consent form [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.

This study is for patients age 18 and older.

Available at: Hartford Hospital and Hospital of Central Connecticut

Cancer Clinical Research Office