A Clinical Study of 6MW3211 in Patients With Renal Cancer

NCT ID: NCT05440045

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-01

Brief Summary

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

Detailed Description

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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

Conditions

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Advanced Clear Cell Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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6MW3211

6MW3211 injection, 30mg/kg

Group Type EXPERIMENTAL

6MW3211

Intervention Type DRUG

6MW3211 injection, 30mg/kg, Q2W

Interventions

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6MW3211

6MW3211 injection, 30mg/kg, Q2W

Intervention Type DRUG

Other Intervention Names

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6MW3211 injection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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6MW3211-2022-CP202

Identifier Type: -

Identifier Source: org_study_id

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