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Long-term treatment with brigimadlin for solid tumours

A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours

PHASE2 · Boehringer Ingelheim · NCT06619509

This study is testing how well adults with solid tumors can tolerate taking brigimadlin long-term after previously being part of a trial with this medication.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim (industry)
Locations56 sites (Beverly Hills, California and 55 other locations)
Trial IDNCT06619509 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term tolerance of brigimadlin in adults with solid tumours who previously participated in a clinical trial involving this medication. Participants are divided into cohorts based on their prior treatment with brigimadlin or a comparator, with those in Cohorts 1b and 2 receiving brigimadlin for the first time. The treatment involves taking brigimadlin tablets once every three weeks, with regular health check-ups and assessments of tumour size and spread. The goal is to gather data on the safety and efficacy of long-term brigimadlin treatment.

Who should consider this trial

Good fit: Ideal candidates include adults who have previously participated in a clinical trial with brigimadlin and are eligible for continued treatment.

Not a fit: Patients who have not previously participated in a trial involving brigimadlin may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of solid tumours using brigimadlin.

How similar studies have performed: Previous studies involving MDM2 inhibitors have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

All patients:

1. Patient is ongoing on brigimadlin treatment or qualifies for crossover to brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
2. Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
3. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of \<1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
4. Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
5. Adequate organ function.
6. All toxicities related to previous anti-cancer therapies have resolved Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and amenorrhea/menstrual disorders which can be any grade and peripheral neuropathy which must be CTCAE Grade ≤2).

   Cohort 1 only:
7. Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.

   Cohort 2 only:
8. Patient is eligible to receive crossover treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients must transition directly from the parent trial to this trial, with no further anti-cancer therapies except those that are allowed by the clinical trial protocol of the parent trial.

Further inclusion criteria apply.

Exclusion criteria:

1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
2. Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
3. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.

   Cohort 1 only:
4. Patient has disease progression or unacceptable toxicity on brigimadlin at the time of transition into this trial.
5. Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
6. Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed between the investigator and the sponsor.

Further exclusion criteria apply.

Where this trial is running

Beverly Hills, California and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumours

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.