A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

Official Title

An Open-label, Phase I Dose Escalation Followed by Dose Expansion Trial in Patients With Advanced Solid Tumours to Investigate Safety, Pharmacokinetics, and Efficacy and to Select the Dose for Further Development of BI 770371 in Combination With Ezabenlimab

Summary:

This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study.

The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab.

BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time.

Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks.

It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly.

The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.

Trial Description

Primary Outcome:

  • Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy
  • Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy
Secondary Outcome:
  • Occurrence of Adverse Events (AEs) during the on-treatment period in monotherapy
  • Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy
  • Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in monotherapy
  • Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society