A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

Advanced Solid Tumours Clinical Trial

Official title:

An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804526
• Other study ID #: RC88 C003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 19, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: RemeGen Co., Ltd.
• Contact: Heping Liu
• Phone: +8610-58075763
• Email: heping.liu[@]remegen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumours

Intervention

Drug:
• RC88
1.5mg/kg ,2.0mg/kg ,2.5mg/kg by intravenous (IV) infusion,every 3 weeks
• Sintilimab Injection
Sintilimab 200mg by intravenous (IV) infusion,every 3 weeks

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RP2D	Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab	28 days after first treatment
Secondary	ORR	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)	24 months
Secondary	Maximum Concentration (Cmax) of RC88	Dose Escalation and Expansion Part	pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
Secondary	Progression Free Survival (PFS)	Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.	24 months