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A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

RECRUITINGPhase 1/2Sponsored by RemeGen Co., Ltd.
Actively Recruiting
PhasePhase 1/2
SponsorRemeGen Co., Ltd.
Started2023-07-19
Est. completion2025-05
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

Advanced Solid TumoursCancer

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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