Status:
UNKNOWN
A Clinical Study of 6MW3211 in Patients With Renal Cancer
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Advanced Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer
Detailed Description
This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer
Eligibility Criteria
Inclusion
- Voluntarily participate in the study and sign the informed consent.
- Advanced clear cell renal cancer.
- At least one measurable tumor target lesion.
- Life expectancy≥3 months.
- Suitable organ functions.
- Patients who had failed at least one line therapy.
- ECOG 0-1.
- The samples of tumor tissue should be provided
Exclusion
- Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
- History of other malignant tumors within 5 years.
- Patients with CNS metastasis.
- History of active autoimmune diseases.
- Patients with poor-controlled systemic diseases after treatment.
- Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing.
- Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
- Patients who had experienced immune-related adverse events (irAE) with grade 3 or above.
- Patients who were allergic to any composition of experimental drug.
- Subjects with poor treatment compliance.
- Pregnant or lactating woman.
- Live vaccination within 28 days before first dosing.
- History of drug abuse or addiction
- Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05440045
Start Date
September 1 2022
End Date
September 1 2024
Last Update
August 17 2022
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