A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

• Status: Recruiting
• Trial end date: 2026-04-30
• Target enrollment: 0
• Participant gender: All

Summary

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotheus Inc.
• Treatments: Paclitaxel

Criteria

Inclusion Criteria:

1. Signed informed consent form before any trial-related processes;

2. Age ≥18 years;

3. Histologically or cytologically confirmed SCLC;

4. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;

5. Have adequate organ function;

6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

7. Life expectancy of ≥12 weeks;

8. Had at least one measurable tumor lesion according to RECIST v1.1.

Exclusion Criteria:

1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;

2. Evidence and history of severe bleeding tendency;

3. History of severe cardiovascular diseases within 6 months;

4. Current presence of severe superior vena cava syndrome and spinal cord compression;

5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;

6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;

7. History of alcohol abuse, psychotropic substance abuse or drug abuse;

8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;

9. Pregnant or lactating women;

10. Other conditions considered unsuitable for this study by the investigator.