A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC
- Registration Number
- NCT05879068
- Lead Sponsor
- Biotheus Inc.
- 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 paclitaxel as second line treatment for SCLC.
- Detailed Description
This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 99
- Signed informed consent form before any trial-related processes;
- Age β₯18 years;
- Histologically or cytologically confirmed SCLC;
- Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
- Have adequate organ function;
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- Life expectancy of β₯12 weeks;
- Had at least one measurable tumor lesion according to RECIST v1.1.
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
- Current presence of severe superior vena cava syndrome and spinal cord compression;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- History of alcohol abuse, psychotropic substance abuse or drug abuse;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PM8002+Paclitaxel PM8002 Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years. PM8002+Paclitaxel Paclitaxel Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years.
- Primary Outcome Measures
Name Time Method Objective Response Rate Up to approximately 2 years Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Treatment related adverse events (TRAEs) Up to 30 days after last treatment The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to approximately 2 years OS is the time from the date of first dosing date to death due to any cause.
Disease control rate (DCR) Up to approximately 2 years DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
Duration of response (DoR) Up to approximately 2 years DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Progression free survival (PFS) Up to approximately 2 years PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Trial Locations
- Locations (11)
Peking University Cancer Hospital
π¨π³Beijing, China
Hunan Cancer Hospital
π¨π³Changsha, China
Sichuan Provincial People's Hospital
π¨π³Chengdu, China
Zhejiang Provincial People's Hospital
π¨π³Hangzhou, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, China
Shandong Cancer Hospital
π¨π³Jinan, China
The First Affiliated Hospital of Nanchang University
π¨π³Nanchang, China
Shanghai Pulmonary Hospital
π¨π³Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
π¨π³Xi'an, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Jilin Provincial Tumor Hospital
π¨π³Changchun, China