A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- HRS-4508+ Capecitabine
- HRS-4508+ Trastuzumab
- HRS-4508+ Trastuzumab+ Pertuzumab
- HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
- HRS-4508+ Trastuzumab + Nab-paclitaxel
- HRS-4508+ Trastuzumab+ Capecitabine
- Trastuzumab+ Capecitabine
- Trastuzumab+ Pertuzumab
- HRS-4508+SHR-A1811
Treatment groups
120 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov