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A Clinical Study of 6MW3211 in Patients With Renal Cancer

Primary Purpose

Advanced Clear Cell Renal Cell Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
6MW3211
Sponsored by
Mabwell (Shanghai) Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Clear Cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    6MW3211

    Arm Description

    6MW3211 injection, 30mg/kg

    Outcomes

    Primary Outcome Measures

    ORR
    Objective response rate

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2022
    Last Updated
    August 14, 2022
    Sponsor
    Mabwell (Shanghai) Bioscience Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05440045
    Brief Title
    A Clinical Study of 6MW3211 in Patients With Renal Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mabwell (Shanghai) Bioscience Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Clear Cell Renal Cell Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    6MW3211
    Arm Type
    Experimental
    Arm Description
    6MW3211 injection, 30mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    6MW3211
    Other Intervention Name(s)
    6MW3211 injection
    Intervention Description
    6MW3211 injection, 30mg/kg, Q2W
    Primary Outcome Measure Information:
    Title
    ORR
    Description
    Objective response rate
    Time Frame
    up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Study of 6MW3211 in Patients With Renal Cancer

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