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Trial Title:
Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
NCT ID:
NCT06439589
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS2398
Description:
HRS2398: Tablets, 40mg/tablet, oral
Arm group label:
HRS2398 given in combination with adebrelimab
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion
Arm group label:
HRS2398 given in combination with adebrelimab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Investigator:
Last name:
Yanyan Liu
Email:
Principal Investigator
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hua Zhong
Start date:
June 12, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06439589
