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A First-in-human, Open-label, Phase I Trial to Determine the Safety and Tolerability of BI 3822971 in Patients With Unresectable Advanced or Metastatic Solid Cancers

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is open to adults with advanced or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer, vulvar cancer, and cervical cancer. People can join the study if they have no remaining standard treatment options and have a measurable lesion outside the central nervous system. The purpose of this study is to find out how well a medicine called BI 3822971 is tolerated in people with these cancers. Researchers also want to find a dose and dosing schedule of BI 3822971 that is safe and is well tolerated. In this study, BI 3822971 is given to humans for the first time. BI 3822971 is being developed to help the immune system fight cancer. This schedule can change during the course of the trial depending on the data generated. All participants receive the study medicine (there is no randomization and no placebo group). Participants visit the study site and may need to stay overnight for observation, especially on days when the medicine is administered. Participants can stay in the study for up to 3 years as long as they benefit from treatment and can tolerate it. During this time, doctors regularly check the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects. They collect information on any health problems of the participants and take blood samples.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), esophageal squamous cell cancer (ESCC), bladder cancer (BC), vulvar cancer (VC) and cervical cancer (CC) and have no remaining standard treatment options (including those who have failed or are intolerant to standard therapy).

• Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the informed consent form (ICF).

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Patient must have at least one measurable lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as measurable lesions only in the absence of measurable lesions that have not been irradiated.

• Further inclusion criteria apply.

Locations
Other Locations
Belgium
UZ Leuven
NOT_YET_RECRUITING
Leuven
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Shanghai East Hospital
NOT_YET_RECRUITING
Shanghai
Germany
Technische Universität Dresden
NOT_YET_RECRUITING
Dresden
Klinikum der Universität München AÖR
NOT_YET_RECRUITING
München
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
NOT_YET_RECRUITING
Amsterdam
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Clínica Universidad de Navarra
RECRUITING
Navarra
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2026-09-21
Estimated Completion Date: 2030-01-15
Participants
Target number of participants: 137
Treatments
Experimental: Dose escalation (all participants)
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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