Loading clinical trials...

A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

NCT05508334•RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Remegen

Beijing, Beijing Municipality, China

Remgenen

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 30, 2023

Primary Completion Date

November 26, 2025

Completion Date

November 26, 2025

Last Updated

December 22, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Solid Tumours

Interventions

RC88

DRUG

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

NCT06815575

Solid TumoursAdvanced Solid Tumours

View study

COMPLETEDPHASE1/PHASE2

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

NCT03518606

Advanced Solid TumoursBreast Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

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

Capivasertib China PK Study

The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors