A Study to Assess the Safety and Tolerability of RC88 for Patients with Advanced Solid Tumours

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumours
• Interventions: Drug: RC88

• Registration Number: NCT05508334
• Lead Sponsor: RemeGen Co., Ltd.

Brief Summary

The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

Detailed Description

The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-19
• Study Start: 2023-01-30
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. All subjects must be ≥ 18 years at the first screening examination / visit.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
3. Life expectancy of at least 12 weeks
4. Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors;
5. Phase II-Advanced malignant solid tumor with MSLN expression
6. Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria
7. Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory.
8. Adequate organ function
9. Voluntarily sign an informed consent form

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
Experimental: RC88	RC88	Subjects will receive intravenous infusion of RC88 once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (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
Terminal Half Life (t1/2) 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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Trial Locations

Locations (2)

Remegen; 🇨🇳 Beijing, Beijing, China

Remgenen; 🇨🇳 Beijing, Beijing, China