A Study to Test How Well Different Doses of BI 3822971 Are Tolerated by People With Advanced Cancer (Solid Tumours)

NCT07744152 | Recruiting Phase 1

• 3 other identifiers: 2015-0001U1111-1337-20132026-525785-22-00
• Study Type: interventional
• Target: 137
• Locations: 5 countries
• Sites: 10

Brief 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.

Conditions

Solid Tumours

Outcome Measures

Primary Outcomes (2)

• Occurrence of treatment-emergent adverse events (AEs)

  up to 36 months

• Occurrence of dose limiting toxicities (DLTs)

  up to 36 months

Secondary Outcomes (2)

• Maximum measured concentration (Cmax) of BI 3822971 in plasma

  up to 36 months

• Area under the concentration-time curve (AUC) of BI 3822971 in plasma

  up to 36 months

Study Arms (1)

Dose escalation (all participants)

EXPERIMENTAL

Drug: BI 3822971

Interventions

BI 3822971 DRUG

BI 3822971

Dose escalation (all participants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention.
• Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration.
• Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV).
• History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of III or IV, corrected QT (QTc) prolongation \> 480 msec, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator.
• Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to treatment.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, 200123, China

NOT YET RECRUITING

Technische Universität Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

Klinikum der Universität München AÖR

München, 81377, Germany

NOT YET RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)

Amsterdam, 1066CX, Netherlands

NOT YET RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Clínica Universidad de Navarra

Navarra, 31008, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

NOT YET RECRUITING

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential cohorts with escalating doses

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): January 15, 2030
• Study Completion (Estimated): January 15, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (5); BE (1); CN (1); DE (2)