NCT05839600Recruiting

A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer

Name: Clinical Trial NCT05839600
Creator: Boehringer Ingelheim
Keywords: Solid Tumors, BI 1821736, Phase 1, drug, clinical trial, United States of America

An Open-label, Phase I Dose Escalation and Expansion Trial to Investigate Safety and Efficacy of BI 1821736 in Patients With Advanced Solid Tumors

Boehringer IngelheimPhase 1ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Solid Tumors
Drug/Device/Intervention: BI 1821736
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Boehringer Ingelheim
Location: San Antonio, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: May 25, 2023
End date: Nov 22, 2025
Enrollment: 27 participants

Primary outcome

Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period

Summary

This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part.  The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time.  Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.

ICD-10 classifications

Malignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm of other connective and soft tissueCarcinoma in situ, unspecifiedMalignant neoplasmsMalignant neoplasm: Parametrium

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05839600
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05839600 through Pure Global AI's free database. This Phase 1 trial is sponsored by Boehringer Ingelheim and is currently Recruiting. The study focuses on Solid Tumors. Target enrollment is 27 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.