BI 770371 for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid TumorsBI 770371 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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: Drug
Combination 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).