TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Summary
This study consists of two parts: Part 1 encompasses a safety lead - in phase and an expansion phase. In both phases, subjects with advanced nasopharyngeal carcinoma who have previously failed platinum - based chemotherapy and immune checkpoint inhibitors (such as anti - PD - 1 monoclonal antibodies/anti - PD - L1 monoclonal antibodies, etc.) will be enrolled. The treatment regimen is TQB2618 combined with penpulimab. During the safety lead - in phase, it is to explore whether two dosage groups of TQB2618 in combination with penpulimab (1200mg/1500mg) are safe and tolerable. If both dosage groups are tolerable, in the expansion phase, an additional 18 to 24 subjects will be enrolled to receive TQB2618 (1500mg) + penpulimab (200mg). If the high dosage (1500mg) of TQB2618 is not tolerated, all subjects will receive TQB2618 (1200mg) + penpulimab (200mg). Part 2 also includes a safety lead - in phase and an expansion phase. It enrolls treatment - naïve subjects with advanced nasopharyngeal carcinoma who have not received prior systemic treatment. These subjects will receive TQB2618 + penpulimab + GP chemotherapy, with the dosage of TQB2618 being 1200mg. In the safety lead - in phase, 3 to 6 subjects will be enrolled. If the treatment combination is safe and tolerable, then in the expansion phase, an additional 24 to 27 subjects will be enrolled. Both parts of the study will be carried out simultaneously
Timeline
- Start
- 2022-10-27
- Primary completion
- 2025-05-28
- Completion
- 2025-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Penpulimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | TQB2618 | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | TQB2618 | Monoclonal antibody | 1500 mg | Intravenous |