Actively Recruiting
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM
Led by Biotheus Inc. · Updated on 2023-06-27
55
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 years or older
- Confirmed malignant mesothelioma by histology without surgical option
- No prior systemic anti-tumor therapy or completed neoadjuvant/adjuvant chemotherapy at least 6 months before recurrence
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable lesion according to mRECIST 1.1 for pleural or RECIST 1.1 for other mesothelioma locations
You will not qualify if you...
- History of severe allergies or allergy to study drug components
- Brain or meningeal metastases with symptoms deemed unsuitable by investigators
- Other active cancers within 5 years except certain locally treated or cured tumors
- Uncontrolled pleural, pericardial, or peritoneal effusions, including those with catheter drainage
- Fever above 38.5°C before starting treatment (unless tumor-related)
- Uncontrolled tumor-related pain or unstable analgesic treatment plan
- Current interstitial lung disease or non-infectious pneumonia except radiation pneumonitis
- Active infections
- History of immunodeficiency including positive HIV test
- Positive syphilis antibody test
- Expecting to receive other anti-tumor drugs during the trial
- Previous allogeneic stem cell or organ transplantation
- Pregnant or lactating women
- Investigator judgment of increased risk or unsuitability for study
- Other reasons judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jilin Provincial Tumor Hospital
Changchun, China
Actively Recruiting
Research Team
L
Linlin Fan
CONTACT
Y
Ying Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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