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A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

NCT06074484 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-10-10

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with AK104 in perioperative treatment of muscle-invasive bladder cancer.

Conditions

  • Muscle Invasive Bladder Carcinoma

Interventions

DRUG

RC48-ADC

4 preoperative cycles of RC48-ADC （2.0 mg/kg，intravenous (IV) infusion，Q2W）, followed by surgery, followed by up to 6 cycles of postoperative RC48-ADC（2.0 mg/kg，intravenous (IV) infusion，Q3W）

DRUG

AK104

4 preoperative cycles of AK104（6.0 mg/kg，intravenous (IV) infusion，Q2W）, followed by surgery, followed by up to 14 cycles of postoperative AK104（10 mg/kg，intravenous (IV) infusion，Q3W）

Sponsors & Collaborators

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Nianzeng Xing, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-10
Primary Completion
2024-08-10
Completion
2025-08-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06074484 on ClinicalTrials.gov