Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07744152

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Solid Tumours

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

  • Further exclusion criteria apply.

Treatment and study plan

BI 3822971

Drug

BI 3822971

Primary outcomes

  1. Occurrence of treatment-emergent adverse events (AEs)

    Time frame: up to 36 months

  2. Occurrence of dose limiting toxicities (DLTs)

    Time frame: up to 36 months

Secondary outcomes

  1. Maximum measured concentration (Cmax) of BI 3822971 in plasma

    Time frame: up to 36 months

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

    Time frame: up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 4, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.