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Obrixtamig · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Combination of obrixtamig and pumitamig in patients with extensive stage small cell lung carcinoma (ES-SCLC) who progressed on or after a platinum-containing first line (1L) treatment or on or after one additional line of therapy (second line (2L) or third line (3L) patients). |
| Cohort 2 | EXPERIMENTAL | Combination of obrixtamig, pumitamig and chemotherapy (i.e., carboplatin and etoposide) in 1L ES-SCLC patients. |
| Name | Type | Description |
|---|---|---|
| Obrixtamig | DRUG | Obrixtamig |
| Pumitamig | DRUG | Pumitamig |
| Carboplatin | DRUG | Carboplatin |
| Etoposide | DRUG | Etoposide |
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. 2. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater tha...
Obrixtamig is an investigational small molecule therapeutic being developed by BioNTech SE for extensive-stage small cell lung carcinoma and advanced small cell lung cancer. It is currently in Phase 1 clinical development and is being studied in combination with another agent called pumitamig.
Obrixtamig is being evaluated for the treatment of extensive-stage small cell lung carcinoma and advanced small cell lung cancer. It is not yet approved for any indication and remains an investigational therapy in Phase 1 testing. The clinical program enrolls adults aged 18 years and older.
Obrixtamig is developed by BioNTech SE, which trades under the ticker BNTX. BioNTech is sponsoring the Phase 1 clinical program evaluating the agent in advanced small cell lung cancer, including the Dareon-Rosetta35 study.
Obrixtamig is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. One Phase 1 trial is currently active, and no trials have been completed to date.
Obrixtamig is being studied in the Phase 1 Dareon-Rosetta35 trial, registered as NCT07843940. The study evaluates obrixtamig in combination with pumitamig in people with advanced small cell lung cancer, plans to enroll 55 participants, and is not yet recruiting. Trial sites span the United States, Australia, Belgium, China, France, Germany, Japan, the Netherlands, Poland, and Spain.