ClinicalTrialsFinder
RecruitingPhase 1Phase 2NCT05804526

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

Sponsor

RemeGen Co., Ltd.

Enrollment

82 participants

Start Date

Jul 19, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumours

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • Voluntary agreement to provide written informed consen
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Predicted survival ≥ 12 weeks
  • 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;
  • Adequate organ function required
  • Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRC88

1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks

DRUGSintilimab Injection

Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks

Locations(1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05804526

Related Trials

Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

NCT0679541215 locations

First in Human Study of AZD9592 in Solid Tumors

NCT0564712250 locations

A Study of EBC-129 in Advanced Solid Tumours

NCT057015275 locations

First in Human Study of SIM0610 in Solid Tumors

NCT073482117 locations

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

NCT068155755 locations