Actively Recruiting
The Efficacy and Safety of IBI363 in Solid Tumors
Led by Hunan Province Tumor Hospital · Updated on 2024-05-30
430
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
Sponsors
H
Hunan Province Tumor Hospital
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.
CONDITIONS
Official Title
The Efficacy and Safety of IBI363 in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Age 18 to 75 years old
- Any gender is eligible
- Phase Ia: Priority given to patients with advanced non-small cell lung cancer or melanoma
- Phase Ib: Includes seven cohorts with advanced melanoma or NSCLC with specific treatment histories or genetic mutations
- At least one measurable tumor lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
You will not qualify if you...
- History of seizures or active central nervous system metastasis or related conditions
- If treated for central nervous system metastases, treatment completed at least 14 days prior with no new or enlarged brain lesions and no steroid use for 14 days
- No symptoms or need for immediate treatment for central nervous system metastases if untreated
- No more than three brain metastatic lesions, each 5 mm or smaller
- Significant cardiovascular or cerebrovascular diseases including uncontrolled arrhythmias, severe conduction problems, QTc interval ≥480 ms, uncontrolled hypertension or hypertensive crisis history, myocarditis history, symptomatic heart failure or low heart function, recent arterial thrombosis or embolism within 6 months, or serious thromboembolic events within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yongchang Zhang
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang Zhang, MD
CONTACT
N
Nong Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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