NCT05918107 A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM
| NCT ID | NCT05918107 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Biotheus Inc. |
| Condition | MPM |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2022-08-13 |
| Primary Completion | 2026-06-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2. Male or female, aged ≥18 years; 3. Malignant mesothelioma confirmed by histology, without indication for surgery; 4. Have not received systemic anti-tumor therapy in the past (if the subject has received neoadjuvant or adjuvant chemotherapy in the past, the last treatment time must be more than 6 months from the time of recurrence); 5. Sufficient organ function; 6. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1; 7. Expected survival period ≥ 12 weeks; 8. There is at least one measurable lesion (malignant pleural mesothelioma is based on mRECIST version 1.1, and malignant mesothelioma in other parts is based on RECIST version 1.1). Exclusion Criteria: 1. History of severe allergic diseases, severe drug (including unmarked test drug) allergy histor