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

NCT05508334 | Completed Phase 1

• 1 other identifier: RC88 C002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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

Conditions

Advanced Solid Tumours

Outcome Measures

Primary Outcomes (1)

• RP2D

  Incidence of DLT (dose limiting toxicity) of RC88

  28 days after first treatment

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  24 months

• Maximum Concentration (Cmax) of RC88

  pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours

• Terminal Half Life (t1/2) 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)

Experimental: RC88

EXPERIMENTAL

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

Drug: RC88

Interventions

RC88 DRUG

Every 2 weeks for a maximum of 2 years

Also known as: The injectable RC88

Experimental: RC88

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must be ≥ 18 years at the first screening examination / visit.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Life expectancy of at least 12 weeks
• 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;
• Phase II-Advanced malignant solid tumor with MSLN expression
• Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria
• Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory.
• Adequate organ function
• Voluntarily sign an informed consent form

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

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (2)

Remegen

Beijing, Beijing Municipality, China

Location

Remgenen

Beijing, Beijing Municipality, China

Location

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: August 1, 2022
• First Posted: August 19, 2022
• Study Start: January 30, 2023
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)