A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours
An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours
1 other identifier
interventional
82
1 country
1
Brief Summary
This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 30, 2024
April 1, 2024
1.8 years
March 26, 2023
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
RP2D
Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab
28 days after first treatment
Secondary Outcomes (3)
ORR
24 months
Maximum Concentration (Cmax) of RC88
pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
Progression Free Survival (PFS)
24 months
Study Arms (1)
RC88+Sintilimab Injection
EXPERIMENTALRC88+Sintilimab Injection Arm
Interventions
1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks
Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks
Eligibility Criteria
You may qualify if:
- Voluntary agreement to provide written informed consen
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Predicted survival ≥ 12 weeks
- 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;
- Adequate organ function required
- Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
You may not qualify if:
- Cancer metastases in the brain
- Active infection or past hepatitis B or C infection
- Major surgery less than 1 month before the start of the study
- Uncontrolled heart disease
- History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Shi Yuankai, M.D.
Leading PI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2023
First Posted
April 7, 2023
Study Start
July 19, 2023
Primary Completion
May 1, 2025
Study Completion
December 1, 2025
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share