A Clinical Study of 6MW3211 in Patients With Renal Cancer

M

Mabwell Bioscience

Status and phase

Not yet enrolling
Phase 2

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Treatments

Drug: 6MW3211

Study type

Interventional

Funder types

Industry

Identifiers

NCT05440045
6MW3211-2022-CP202

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

6MW3211
Experimental group
Description:
6MW3211 injection, 30mg/kg
Treatment:
Drug: 6MW3211

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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