A Phase 2 Study of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.