Status:
UNKNOWN
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced Malignant Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advance...
Eligibility Criteria
Inclusion
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
- Histopathologically or cytologically documented advanced or metastatic malignancies;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥12 weeks;
- Adequate organ functions as defined;
- Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.
Exclusion
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- Patients with tumor-related pain that cannot be controlled as determined by the investigator;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
- Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
- Patients who have received \>30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
- Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy;
- Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
- Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
- Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- History of autoimmune diseases;
- History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
- History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
- Evidence or history of arterial/venous thrombosis within 3 months before the first dose;
- Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
- Known history of serious allergic reactions to the investigational product or its main ingredients;
- History of immunodeficiency;
- Presence of active hepatitis B or active hepatitis C;
- Severe infections within 4 weeks prior to the first study treatment;
- Evidence or history of active pulmonary tuberculosis within 1 year before study entry;
- any other conditions that are not suitable for participation in the study in the investigator's opinion.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05198817
Start Date
February 22 2022
End Date
June 30 2023
Last Update
June 28 2022
Active Locations (5)
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1
Henan Science and Technology University First Affiliated Hospital
Luoyang, Henan, China, 471003
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410006
3
Linyi Cancer Hospital
Linyi, Shandong, China, 276002
4
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433