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NCT07929051
A Study to Test Obrixtamig Treatment in People With Different Types of Advanced Cancer Who Took Part in a Previous Study With Obrixtamig
Conditions: Advanced Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 68
Sponsor: Boehringer Ingelheim
Location: Universitair Ziekenhuis Gent Ghent
Summary
This study is open to adults with advanced cancer who received obrixtamig (BI 764532) in one of several previous studies and benefited from treatment. The goal of this study is to find out how well participants who received obrixtamig in a previous study tolerate obrixtamig. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer.
Participants in this study continue receiving obrixtamig and any other study or standard of care anti-cancer medicines they received in their previous study at the same doses and following the same treatment schedule. Treatments are given in 3-week cycles as infusions into a vein.
Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. During the visits, study doctors check participants' health and take note of any unwanted effects.
Eligibility Criteria
Inclusion criteria :
1. Patient is ongoing on obrixtamig treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial') that has achieved data cut-off for final analysis.
2. Patient is benefiting from obrixtamig treatment according to investigators' assessment in the parent trial. Patients who experienced progressive disease in the parent trial will be eligible for the rollover trial, if treatment beyond progression has been agreed between the sponsor and investigators in the parent trial provided that patient is considered to derive clinical benefit.
3. Patient meets the criteria for further obrixtamig treatment as defined in the clinical trial protocol of the parent trial they are currently participating in. Patients with ongoing dose delays due to adverse events in the parent trial are eligible, provided recovery from the adverse event takes place within the allowed time window in the parent trial.
4. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
5. 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 obrixtamig.
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 participating in the trial.
4. Patients who are institutionalized due to regulatory or juridical order; or dependent on sponsor, site or investigator.
5. Further exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07929051). StuddyBuddy aggregates publicly available trial information.