NCT04147234 - 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) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 3, 2020

Primary Completion Date

November 15, 2022

Study Completion Date

March 21, 2024

Conditions

Neoplasms

Interventions

DRUG

BI 1387446 50 μg

Participants received 50 μg BI 1387446 intratumorally based on tumor diameter, on Day 1 of a 21-day cycle. Injections were administered under visual inspection for skin tumors or imaging guidance.

DRUG

BI 754091

Participants received BI 754091 (ezabenlimab) intravenously at a dose of 240 mg once every 21-day cycle.

DRUG

BI 1387446 100 μg

Participants received 100 μg BI 1387446 intratumorally based on tumor diameter, on Day 1 of a 21-day cycle. Injections were administered under visual inspection for skin tumors or imaging guidance.

DRUG

BI 1387446 200 μg

Participants received 200 μg BI 1387446 intratumorally based on tumor diameter, on Day 1 of a 21-day cycle. Injections were administered under visual inspection for skin tumors or imaging guidance.

DRUG

BI 1387446 400 μg

Participants received 400 μg BI 1387446 intratumorally based on tumor diameter, on Day 1 of a 21-day cycle. Injections were administered under visual inspection for skin tumors or imaging guidance.

Trial Locations (8)

27514

The University of North Carolina at Chapel Hill, Chapel Hill

28050

CIO Clara Campal, Madrid

46010

Hospital Clínico de Valencia, Valencia

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

08035

Hospital Vall d'Hebron, Barcelona

SW3 6JJ

The Royal Marsden Hospital, Chelsea, London

OX3 7LE

Churchill Hospital, Oxford

SM2 5PT

The Royal Marsden Hospital, Sutton, Sutton