A Clinical Study of 6MW3211 in Patients With Renal Cancer

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05440045

Enrollment

Registered

2022-06-30

Start date

2022-09-01

Completion date

2024-09-01

Last updated

2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Clear Cell Renal Cell Carcinoma

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

Interventions

DRUG6MW3211

6MW3211 injection, 30mg/kg, Q2W

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
ORR	up to 24 months	Objective response rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026