Lung Cancer
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.
Interventions
DRUGHRS-4508 tablet
PartA ：HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB：HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC：HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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. Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens. 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; Experiencing traumatic minor surgery within 7 days prior to the first administration of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | 1 year |
| Dose limiting toxicity (DLT) | 2 month |
| Maximum tolerated dose (MTD) | 2 month |
| Determine dose recommendation (RP2D) | 6month |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 1 years |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentrations of HRS-4508 and SHR-A1811 | 12 weeks |
| Duration of response (DoR) | 1 year |
| Disease control rate (DCR) | 1 year |
| Progression free survival (PFS) | 1 year |
| Overall survival (OS) | 2 year |
Countries
China
Contacts
Primary ContactLiju Zong
Outcome results
None listed