NCT06439589RecruitingPhase 1
An Open-label, Multi-center Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Shanghai Hengrui Pharmaceutical Co., Ltd.2 sites in 1 country88 target enrollmentStarted: June 12, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Determination of Recommended Phase II dose (RP2D)
Study Overview
Brief Summary
This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.
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
- •Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- •Age 18~75 years old.
- •Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.
- •Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings.
- •At least one measurable lesion per RECIST v1.1 criteria.
- •ECOG PS score: 0-1.
Exclusion Criteria
- •Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.
- •Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.
- •Presence of any active, known autoimmune disease.
Arms & Interventions
HRS2398 given in combination with adebrelimab
Experimental
Intervention: HRS2398 (Drug)
HRS2398 given in combination with adebrelimab
Experimental
Intervention: Adebrelimab (Drug)
Outcomes
Primary Outcomes
Determination of Recommended Phase II dose (RP2D)
Time Frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）
Objective Response Rate (ORR)
Time Frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
The number of subjects with dose-limiting toxicity (DLT)
Time Frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）
Secondary Outcomes
- Overall Survival (OS)(From time of first dose of objective disease progression until the date of death (up to 24 months))
- Disease Control Rate (DCR)(From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months))
- Time To Response(TTR)(From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months))
- Duration of Response (DoR)(From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months))
- Progression free Survival (PFS)(From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months))
Investigators
Study Sites (2)
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