Advanced Solid Tumors
Conditions
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.
Interventions
DRUGHRS2398
HRS2398: Tablets, 40mg/tablet, oral
DRUGAdebrelimab
Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion
Sponsors
Shanghai Hengrui Pharmaceutical 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. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. Age 18\ 75 years old. 3. 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. 4. 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. 5. At least one measurable lesion per RECIST v1.1 criteria. 6. ECOG PS score: 0-1.
Exclusion criteria
1. Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy. 2. 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. 3. Presence of any active, known autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of subjects with dose-limiting toxicity (DLT) | From first dose of study treatment until the end of Cycle 1（up to 28 days） |
| Determination of Recommended Phase II dose (RP2D) | From first dose of study treatment until the end of Cycle 1（up to 28 days） |
| Objective Response Rate (ORR) | From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| Overall Survival (OS) | From time of first dose of objective disease progression until the date of death (up to 24 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) |
Countries
China
Contacts
Primary ContactXin Xu
Backup ContactYuting Wang
Outcome results
None listed