Study on Efficacy and Safety of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Dose limiting toxicity (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18 to 75 years old; Both men and women are welcome;
- •Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens.
- •ECOG ratings of 0 or
- •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; Experiencing traumatic minor surgery within 7 days prior to the first administration of medication
Arms & Interventions
Part A/B/C
PartA：HRS-4508 tablet+SHR-A1811 PartB：HRS-4508 tablet+ Adebrelimab Injection PartC：HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection
Intervention: HRS-4508 tablet (Drug)
Outcomes
Primary Outcomes
Dose limiting toxicity (DLT)
Time Frame: 2 month
Maximum tolerated dose (MTD)
Time Frame: 2 month
Determine dose recommendation (RP2D)
Time Frame: 6month
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time Frame: 1 years
Objective response rate (ORR)
Time Frame: 1 year
Secondary Outcomes
- Disease control rate (DCR)(1 year)
- Progression free survival (PFS)(1 year)
- Blood concentrations of HRS-4508 and SHR-A1811(12 weeks)
- Overall survival (OS)(2 year)
- Duration of response (DoR)(1 year)