A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-4508+ Capecitabine, HRS-4508+ Trastuzumab, HRS-4508+ Trastuzumab+ Pertuzumab, HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
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.
Interventions
- Drug HRS-4508+ Capecitabine
HRS-4508+ Capecitabine - Drug HRS-4508+ Trastuzumab
HRS-4508+ Trastuzumab - Drug HRS-4508+ Trastuzumab+ Pertuzumab
HRS-4508+ Trastuzumab+ Pertuzumab - Drug HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel - Drug HRS-4508+ Trastuzumab + Nab-paclitaxel
HRS-4508+ Trastuzumab + Nab-paclitaxel - Drug HRS-4508+ Trastuzumab+ Capecitabine
HRS-4508+ Trastuzumab+ Capecitabine - Drug Trastuzumab+ Capecitabine
Trastuzumab+ Capecitabine - Drug Trastuzumab+ Pertuzumab
Trastuzumab+ Pertuzumab - Drug HRS-4508+SHR-A1811
HRS-4508+SHR-A1811
Primary outcome measures
- HRS4508 DLT [Time frame: 3 weeks]
- HRS4508 MTD [Time frame: 12 weeks]
- HRS4508 RP2D [Time frame: 12 weeks]
- The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) [Time frame: 2 years]
- Objective response rate (ORR) [Time frame: 1 year]
Secondary outcome measures (11)
- Blood concentrations of HRS-4508 [Time frame: 15 weeks]
- Blood concentrations of SHR-A1811 [Time frame: 9 weeks]
- Blood concentrations of Capecitabine [Time frame: 2 weeks]
- Objective response rate (ORR) [Time frame: 1 year]
- Best overall efficacy (BOR) [Time frame: 1 year]
- Duration of response (DoR) [Time frame: 1 year]
- Progression free survival (PFS) [Time frame: 1 year]
- Disease control rate (DCR) [Time frame: 1 year]
- Overall survival (OS) [Time frame: 2 year]
- The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) [Time frame: 2 years]
- Blood concentrations of Paclitaxel for Injection [Time frame: 6 weeks]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Science — Beijing
Identifiers
NCT: NCT07140393 · HRS-4508-202-BC