Status:
UNKNOWN
A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor t...
Eligibility Criteria
Inclusion
- Age 18 to 75 years old (inclusive), Female or male
- Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
- Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
- At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
- ECOG performance score of 0-1;
- Expected survival time ≥ 12 weeks;
- Adequate bone marrow and organ function
- Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Exclusion
- Subjects with active central nervous system (CNS) metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
- Subjects with uncontrolled tumor-related pain
- Clinically uncontrollable third space fluid
- Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
- Serious cardiovascular disease
- Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
- Presence of severe infection within 4 weeks prior to first dose of study drug
- Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
- Arterial/venous thrombotic events within 3 months prior to the first study dose
- History of immunodeficiency, including a positive HIV test
- Presence of active hepatitis B or C;
- History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
- Known history of alcohol or drug dependence or addiction;
- Persons with mental disorders or poor compliance;
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06092268
Start Date
October 1 2023
End Date
December 1 2025
Last Update
October 23 2023
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