A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

Phase 1

Recruiting

• Conditions: Advanced Solid Tumours
• Interventions: Drug: RC88; Drug: Sintilimab Injection

• Registration Number: NCT05804526
• Lead Sponsor: RemeGen Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Study First Posted: 2023-04-07
• Study Start: 2023-07-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RC88+Sintilimab Injection	RC88	RC88+Sintilimab Injection Arm
RC88+Sintilimab Injection	Sintilimab Injection	RC88+Sintilimab Injection Arm

Primary Outcome Measures

Name	Time	Method
RP2D	28 days after first treatment	Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab

Secondary Outcome Measures

Name	Time	Method
ORR	24 months	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Maximum Concentration (Cmax) of RC88	pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours	Dose Escalation and Expansion Part
Progression Free Survival (PFS)	24 months	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.

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China