Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing BI 3968621 for Advanced Solid Tumour

This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. this study wants to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab.

Official registry: https://clinicaltrials.gov/study/NCT07851103 · Boehringer Ingelheim · enrollment listed as 90

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BI 3968621, or ezabenlimab. The registry lists allocation as randomized. This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body.

They plan to enroll about 90 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A First-in-human, Multicentre, Phase Ia Dose Escalation Study of BI 3968621 as Monotherapy and in Combination With Ezabenlimab to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity in Patients With Advanced Solid Tumours

Interventions: BI 3968621, ezabenlimab

Primary outcome (registry wording): Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Male and female participants ≥18 years of age and at least at the legal age of consent
  • At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
  • Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria
  • Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further who can join apply

Public study contact (from the registry)

Boehringer Ingelheim

018002430127

clintriage.rdg@boehringer-ingelheim.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

10 listed

+ 5 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07851103 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07851103?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07851103?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary