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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