Solid Tumor
Conditions
Brief 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.
Interventions
DRUGHRS-4508+ Capecitabine
HRS-4508+ Capecitabine
DRUGHRS-4508+ Trastuzumab
HRS-4508+ Trastuzumab
DRUGHRS-4508+ Trastuzumab+ Pertuzumab
HRS-4508+ Trastuzumab+ Pertuzumab
DRUGHRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
DRUGHRS-4508+ Trastuzumab + Nab-paclitaxel
HRS-4508+ Trastuzumab + Nab-paclitaxel
DRUGHRS-4508+ Trastuzumab+ Capecitabine
HRS-4508+ Trastuzumab+ Capecitabine
DRUGTrastuzumab+ Capecitabine
Trastuzumab+ Capecitabine
DRUGTrastuzumab+ Pertuzumab
Trastuzumab+ Pertuzumab
DRUGHRS-4508+SHR-A1811
HRS-4508+SHR-A1811
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRS4508 DLT | 3 weeks |
| HRS4508 MTD | 12 weeks |
| HRS4508 RP2D | 12 weeks |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 2 years |
| Objective response rate (ORR) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentrations of HRS-4508 | 15 weeks |
| Blood concentrations of SHR-A1811 | 9 weeks |
| Blood concentrations of Capecitabine | 2 weeks |
| Objective response rate (ORR) | 1 year |
| Best overall efficacy (BOR) | 1 year |
| Duration of response (DoR) | 1 year |
| Progression free survival (PFS) | 1 year |
| Disease control rate (DCR) | 1 year |
| Overall survival (OS) | 2 year |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 2 years |
| Blood concentrations of Paclitaxel for Injection | 6 weeks |
Countries
China
Contacts
CONTACTJiaman Lin
CONTACTYadan Huo
Outcome results
None listed