A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine

Boehringer Ingelheim

Status and phase

Enrolling

Phase 2

Conditions

Solid Tumours

Treatments

Drug: Brigimadlin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06619509

1403-0032

2024-514177-21-00 (Registry Identifier)

U1111-1305-3484 (Registry Identifier)

Details and patient eligibility

About

This study is open to adults who participated in a previous clinical study with brigimadlin.

The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer.

Participants are grouped in cohorts depending on their treatment in the previous study:

Cohort 1a got brigimadlin and continues treatment with brigimadlin
Cohort 1b got brigimadlin for 4 or less treatment cycles; each cycle was 3 weeks long
Cohort 2 received a comparator and gets brigimadlin for the first time

All participants take brigimadlin as tablets once every 3 weeks at the study site. Participants in the Cohorts 1b and 2 visit the sites more frequently. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body.

Participants are in the study as long as they benefit from treatment and can tolerate it.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients:

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').
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.
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.
Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
Adequate organ function.
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:
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:
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

Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
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:
Patient has disease progression or unacceptable toxicity on brigimadlin at the time of transition into this trial.
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.
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.