A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

RemeGen

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumours

Treatments: Drug: Sintilimab Injection; Drug: RC88

Study type: Interventional

Funder types: Industry

Identifiers

NCT05804526

RC88 C003

Details and patient eligibility

About

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

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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82 participants in 1 patient group

RC88+Sintilimab Injection

Experimental group

Description:

RC88+Sintilimab Injection Arm

Treatment:

Drug: RC88

Drug: Sintilimab Injection