To hear about similar clinical trials, please enter your email below

Trial Title: A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

NCT ID: NCT05508334

Condition: Advanced Solid Tumours

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: RC88
Description: Every 2 weeks for a maximum of 2 years
Arm group label: Experimental: RC88

Other name: The injectable RC88

Summary: The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

Detailed description: The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. All subjects must be ≥ 18 years at the first screening examination / visit. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 3. Life expectancy of at least 12 weeks 4. Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors; 5. Phase II-Advanced malignant solid tumor with MSLN expression 6. Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria 7. Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory. 8. Adequate organ function 9. Voluntarily sign an informed consent form Exclusion Criteria: 1. Cancer metastases in the brain 2. Active infection or past hepatitis B or C infection 3. Major surgery less than 1 month before the start of the study 4. Uncontrolled heart disease 5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Remegen

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Xiaohong Su, M.D

Phone: +0810-65391479
Email: xiaohong.su@remegen.cn

Investigator:
Last name: Yuankai Shi, M.D
Email: Principal Investigator

Investigator:
Last name: Ziping Wang, M.D
Email: Principal Investigator

Investigator:
Last name: Peng Zhang, M.D
Email: Principal Investigator

Investigator:
Last name: Ying Cheng, M.D
Email: Principal Investigator

Investigator:
Last name: DongYun Zhu, M.D
Email: Principal Investigator

Investigator:
Last name: Yan Zhang, M.D
Email: Principal Investigator

Investigator:
Last name: XiaoRong Dong, M.D
Email: Principal Investigator

Facility:
Name: Remgenen

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Xiaohong Su, M.D.

Phone: +8610-65391479
Email: xiaohong.su@remegen.cn

Investigator:
Last name: Yuankai Shi, M.D.
Email: Principal Investigator

Investigator:
Last name: Ziping Wang, M.D.
Email: Principal Investigator

Investigator:
Last name: Peng Zhang, M.D.
Email: Principal Investigator

Investigator:
Last name: DongYun Zhu, M.D.
Email: Principal Investigator

Investigator:
Last name: Yan Zhang, M.D.
Email: Principal Investigator

Investigator:
Last name: XiaoRong Dong, M.D.
Email: Principal Investigator

Start date: January 30, 2023

Completion date: December 30, 2024

Lead sponsor:
Agency: RemeGen Co., Ltd.
Agency class: Industry

Source: RemeGen Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05508334

Login to your account

Did you forget your password?