Actively Recruiting
Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-07-05
88
Participants Needed
2
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give voluntary informed consent and willing to complete all study procedures
- Age between 18 and 75 years old
- For dose escalation: advanced solid tumors confirmed clinically or pathologically, with failed standard therapy or no effective treatment
- For dose expansion and efficacy phases: advanced solid tumors with prior systemic immunotherapy and platinum-containing chemotherapy
- At least one measurable tumor lesion as per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
You will not qualify if you...
- Presence of meningeal metastases or untreated brain metastases
- Cancerous ascites or pleural effusion with symptoms requiring drainage, or drainage received within 14 days before first dose
- Any active, known autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
2
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
Research Team
X
Xin Xu
CONTACT
Y
Yuting Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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