NCT05440045

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 17, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

June 27, 2022

Last Update Submit

August 14, 2022

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective response rate

    up to 24 months

Study Arms (1)

6MW3211

EXPERIMENTAL

6MW3211 injection, 30mg/kg

Drug: 6MW3211

Interventions

6MW3211DRUG

6MW3211 injection, 30mg/kg, Q2W

Also known as: 6MW3211 injection
6MW3211

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2024

Study Completion

September 1, 2024

Last Updated

August 17, 2022

Record last verified: 2022-06