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A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

Recruiting
18-75 years
All
Phase 1/2

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Overview

The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.

Eligibility

Inclusion Criteria:

  1. Age: 18 to 75 years old; Both men and women are welcome;
  2. The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
  3. ECOG ratings of 0 or 1.
  4. Expected survival period ≥ 12 weeks.
  5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
  6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.

Exclusion Criteria:

  1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
  2. There have been significant severe infections and major surgeries in the past 4 weeks
  3. Existence of previous or concurrent malignant tumors
  4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
  5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;

Study details
    Solid Tumor

NCT07140393

Jiangsu HengRui Medicine Co., Ltd.

4 July 2026

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FAQs

Learn more about clinical trials

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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