Testing different dose levels of BI 3822971 in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study administers BI 3822971 to adults with unresectable or metastatic solid tumors to determine tolerability and establish a safe dosing plan. The trial has no randomization and all participants receive the treatment, with dose adjustments allowed based on safety data. Eligible cancers include NSCLC, HNSCC, TNBC, ESCC, bladder, vulvar, and cervical cancers, and require measurable disease outside the CNS. Enrollment is restricted to sites in Belgium and China, with adults who have good performance status and accessible disease lesions. The study focuses on safety, tolerability, and dose optimization to inform future research.

Why it matters

Who can join: the full rules

Inclusion criteria :

1. 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).
2. 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).
3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. 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.
5. Further inclusion criteria apply.

Exclusion criteria :

1. Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention.
2. Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration.
3. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV).
4. 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.
5. Further exclusion criteria apply.

Where it's running

• Hospital del Mar
  Barcelona, Spain Recruiting
• Hospital Universitari Vall d'Hebron
  Barcelona, Spain Recruiting
• Hospital Universitario 12 de Octubre
  Madrid, Spain Recruiting
• Clínica Universidad de Navarra
  Navarra, Spain Recruiting
• Hospital Clinico Universitario de Valencia
  Valencia, Spain Recruiting
• UZ Leuven
  Leuven, Belgium Not yet recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.