Study Summary
This trial is for adults with advanced cancer who have no other treatment options. The purpose is to find the highest dose of BI 770371 that people can tolerate when taken alone or with ezabenlimab.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: up to 2 years
21 days
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy
up to 2 years
Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy
Occurrence of Adverse Events (AEs) during the on-treatment period in monotherapy
Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy
Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in monotherapy
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Monotherapy dose escalation
1 of 2
Combination therapy dose escalation
1 of 2
Experimental Treatment
42 Total Participants · 2 Treatment Groups
Primary Treatment: BI 770371 · No Placebo Group · Phase 1
Monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: BI 770371 · Intervention Types: DrugCombination therapy dose escalationExperimental Group · 2 Interventions: ezabenlimab, BI 770371 · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,384 Previous Clinical Trials
9,803,741 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have given informed consent to participate in the trial.
You have a disease that is not responsive to existing therapies or for which no therapy of proven efficacy exists or for which you are not eligible for established treatment options (including anti-PD-1 or anti-PD-L1 therapies, if relevant).
You have at least one measurable lesion according to RECIST v1.1.
You have a 0 to 1 ECOG score.
You have a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type).
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Conditions
Cancer Related
Treatments