A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor (NCT07140393) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
China120 participantsStarted 2025-10-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HRS4508 DLT
Timeframe: 3 weeks
2
HRS4508 MTD
Timeframe: 12 weeks
3
HRS4508 RP2D
Timeframe: 12 weeks
4
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
. 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;