A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 1387446; Drug: BI 754091

• Registration Number: NCT04147234
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a study in adults with advanced cancer (solid tumours) in whom previous treatment was not successful. The study tests 2 medicines called BI 1387446 and BI 754091. Both medicines may help the immune system fight cancer. In this study, BI 1387446 is given to humans for the first time.

The purpose of this study is to find out the highest dose of BI 1387446 alone and in combination with BI 754091 the participants can tolerate. BI 1387446 is injected directly into the tumour.

Participants get BI 1387446 injections every week at the beginning and then every 3 weeks.

Some participants get BI 754091 in addition to BI 1387446. BI 754091 is given as an infusion into a vein every 3 weeks.

As long as they benefit from treatment and can tolerate it, participants can stay in the study for up to 2 years and 8 months. During this time, they visit the study site regularly. At these visit, doctors record any unwanted effects. The doctors also regularly check participants' health.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Study Start: 2020-08-03
• Primary Completion: 2022-11-15
• Study Completion: 2024-03-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: BI 1387446	BI 1387446	superficial lesions
Arm B: BI 1387446 in combination with ezabenlimab (BI 754091)	BI 1387446	superficial lesions
Arm B: BI 1387446 in combination with ezabenlimab (BI 754091)	BI 754091	superficial lesions

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) based on number of Dose-limiting toxicities (DLTs)	3 weeks
Number of patients with Dose limiting Toxicity (DLT) in the Maximum tolerated dose (MTD) evaluation period	up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Objective response	An average of 1 year
Best percentage change from baseline in size of injected target lesions	An average of 1 year
Best percentage change from baseline in size of non-injected target lesions	An average of 1 year

Trial Locations

Locations (7)

Hospital Vall d'Hebron-Barcelona-47683; 🇪🇸 Barcelona, Spain

Froedtert and The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

CIO Clara Campal; 🇪🇸 Madrid, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

The Royal Marsden Hospital, Chelsea; 🇬🇧 London, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

The Royal Marsden Hospital, Sutton; 🇬🇧 Sutton, United Kingdom