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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumours
• Intervention / Treatment: Drug: RC88; Drug: Sintilimab Injection

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Heping Liu; Phone Number: +8610-58075763; Email: heping.liu@remegen.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Yuankai Shi, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RC88+Sintilimab Injection; RC88+Sintilimab Injection Arm	Drug: RC88; 1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks; Drug: Sintilimab Injection; Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks; Other Names: Sintilimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RP2D	Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab	28 days after first treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ORR	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)	24 months
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

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Study Director: Shi Yuankai, M.D., Leading PI

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RC88 C003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No