A Clinical Study of 6MW3211 in Patients With Renal Cancer

Advanced Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05440045
• Other study ID #: 6MW3211-2022-CP202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Clear Cell Renal Cell Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

Drug:
• 6MW3211
6MW3211 injection, 30mg/kg, Q2W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate	up to 24 months