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

NCT07744152 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-08-04

No results posted yet for this study

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

Interventions

DRUG

BI 3822971

BI 3822971

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2030-01-15
Completion
2030-01-15

Countries

  • Belgium
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744152 on ClinicalTrials.gov