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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional study in phase 1/2 that looks at safety, how well the drug works, and the recommended dose when HRS-4508 is used with other anti-tumor therapies such as capecitabine, trastuzumab, pertuzumab, and nab-paclitaxel. Researchers will determine the maximum tolerated dose and recommended phase 2 dose, monitor adverse events, and measure response rates by RECIST v1.1. Pharmacokinetics of HRS-4508 and SHR-1811 will also be characterized. Eligible patients have unresectable or metastatic solid tumors, adequate organ function, and at least one measurable lesion.

Why it matters

Who can join: the full rules

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;

Where it's running

• Cancer Hospital Chinese Academy of Medical Science
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiaman Lin
• Email: jiaman.lin@hengrui.com
• Phone: +86 180 0245 4915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.