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A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

Recruiting
18-70 years
All
Phase 1/2

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Overview

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

Eligibility

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

Study details
    Advanced Solid Tumours

NCT05804526

RemeGen Co., Ltd.

16 May 2024

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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