🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05879068
Active, not recruiting Phase 2

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

NCT05879068 · tracked via the Priya Life Science China tracker
Sponsor
Biotheus Inc.
Phase
Phase 2
Started
2022-05-27
Last updated
2024-12-18

Condition(s) studied

SCLC

Investigational drug(s) / intervention(s)

PM8002Paclitaxel

PM8002: IV infusion

Paclitaxel: IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing China
Jilin Provincial Tumor Hospital Changchun China
Hunan Cancer Hospital Changsha China
Sichuan Provincial People's Hospital Chengdu China
Zhejiang Provincial People's Hospital Hangzhou China
Harbin Medical University Cancer Hospital Harbin China
Shandong Cancer Hospital Jinan China
The First Affiliated Hospital of Nanchang University Nanchang China
Shanghai Pulmonary Hospital Shanghai China
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China
Henan Cancer Hospital Zhengzhou China

More Biotheus Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05879068 on ClinicalTrials.gov ↗ ← All trials in China