At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic cancer not amenable to curative treatment
- ✓Small cell lung carcinoma (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), neuroendocrine carcinoma (NEC), or small cell carcinoma of other origin
- ✓DLL3 expression positive confirmed by central pathology review
- ✓Mixed histology tumors eligible only if neuroendocrine component is predominant and ≥50% of tumor tissue
- ✕Prior treatment with T cell Engager (TcE) or cell therapies targeting DLL3
- ✕Anticoagulant treatment that cannot be safely interrupted
- ✕Persistent toxicity from previous treatments not resolved to CTCAE Grade 1
- ✕Immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days prior to first dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A First-In-human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of Obrixtamig (BI 764532) Administered by Parenteral Route in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
In Brief
A Phase 1 clinical trial evaluating Obrixtamig - parenteral 1 and Obrixtamig - parenteral 2 for Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3. Currently recruiting, targeting 300 participants across 12 sites in 4 countries.
Detailed Summary
This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of obrixtamig and the best treatment schedule that people can tolerate. Obrixtamig is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, obrixtamig is given to people for the first time. Interim clinical data are available for obrixtamig. Participants get obrixtamig either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Study Details
Timeline
Interventions
Obrixtamig - parenteral 1
Obrixtamig - parenteral 2