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A Clinical Study of 6MW3211 in Patients With Renal Cancer

Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05440045
Collaborator
(none)
30
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6MW3211

6MW3211 injection, 30mg/kg

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR [up to 24 months]

      Objective response rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mabwell (Shanghai) Bioscience Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mabwell (Shanghai) Bioscience Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05440045
    Other Study ID Numbers:
    • 6MW3211-2022-CP202
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell
    Kidney Neoplasms

    Study Results

    No Results Posted as of Aug 17, 2022