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NCT Number: NCT07140393

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Fei Ma

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HRS-4508+ Capecitabine

Drug

HRS-4508+ Capecitabine

HRS-4508+ Trastuzumab

Drug

HRS-4508+ Trastuzumab

HRS-4508+ Trastuzumab+ Pertuzumab

Drug

HRS-4508+ Trastuzumab+ Pertuzumab

HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel

Drug

HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel

HRS-4508+ Trastuzumab + Nab-paclitaxel

Drug

HRS-4508+ Trastuzumab + Nab-paclitaxel

HRS-4508+ Trastuzumab+ Capecitabine

Drug

HRS-4508+ Trastuzumab+ Capecitabine

Trastuzumab+ Capecitabine

Drug

Trastuzumab+ Capecitabine

Trastuzumab+ Pertuzumab

Drug

Trastuzumab+ Pertuzumab

HRS-4508+SHR-A1811

Drug

HRS-4508+SHR-A1811

Primary outcomes

  1. HRS4508 DLT

    Time frame: 3 weeks

  2. HRS4508 MTD

    Time frame: 12 weeks

  3. HRS4508 RP2D

    Time frame: 12 weeks

  4. The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)

    Time frame: 2 years

  5. Objective response rate (ORR)

    Time frame: 1 year

Secondary outcomes

  1. Blood concentrations of HRS-4508

    Time frame: 15 weeks

  2. Blood concentrations of SHR-A1811

    Time frame: 9 weeks

  3. Blood concentrations of Capecitabine

    Time frame: 2 weeks

  4. Objective response rate (ORR)

    Time frame: 1 year

  5. Best overall efficacy (BOR)

    Time frame: 1 year

  6. Duration of response (DoR)

    Time frame: 1 year

  7. Progression free survival (PFS)

    Time frame: 1 year

  8. Disease control rate (DCR)

    Time frame: 1 year

  9. Overall survival (OS)

    Time frame: 2 year

  10. The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)

    Time frame: 2 years

  11. Blood concentrations of Paclitaxel for Injection

    Time frame: 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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