A Clinical Study of 6MW3211 in Patients With Renal Cancer

Phase 2

Not yet recruiting

• Conditions: Advanced Clear Cell Renal Cell Carcinoma
• Interventions: Drug: 6MW3211

• Registration Number: NCT05440045
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Last Update Submitted: 2022-08-14
• Last Update Posted: 2022-08-17
• Study Start: 2022-09-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
6MW3211	6MW3211	6MW3211 injection, 30mg/kg

Primary Outcome Measures

Name	Time	Method
ORR	up to 24 months	Objective response rate