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Trial Title:
A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours
NCT ID:
NCT05804526
Condition:
Advanced Solid Tumours
Study type:
Interventional
Study phase:
Phase 1/Phase 2
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:
1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks
Arm group label:
RC88+Sintilimab Injection
Intervention type:
Drug
Intervention name:
Sintilimab Injection
Description:
Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks
Arm group label:
RC88+Sintilimab Injection
Other name:
Sintilimab
Summary:
This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88
combined with Sintilimab in advancedsolid tumours
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary agreement to provide written informed consen
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
3. Predicted survival ≥ 12 weeks
4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by
central laboratory).Failure, intolerance, or lack of standard treatment has been
identified by tissue or cytology The MSLN test is not required for patients with
advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;
5. Adequate organ function required
6. Male and female participants are eligible to participate if they agree to the
contraception use as per study protocol.
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:
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuankai Shi, Ph.D
Start date:
July 19, 2023
Completion date:
December 2025
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/NCT05804526
