Actively Recruiting
Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-01-22
198
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.
CONDITIONS
Official Title
Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously treated with a third-generation EGFR tyrosine kinase inhibitor with disease progression
- Patients with positive other driver genes or METex14 mutations must have undergone targeted therapy and have disease progression
You will not qualify if you...
- Received live vaccines within 4 weeks before the first dose or plan to receive live vaccines during the study
- Infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose (except compliant antiviral therapy for hepatitis B or C)
- Known HIV infection or HIV antibody positive
- Acute or chronic active hepatitis B or C with specified viral load levels
- Active COVID-19 infection requiring treatment or hospitalization
- Active tuberculosis infection or treatment within 1 year prior to first dose
- Active or latent syphilis requiring treatment
- Symptomatic congestive heart failure Grade II-IV or uncontrolled arrhythmias
- QTc interval greater than 480 ms or family history of congenital long/short QT syndrome
- Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
- History of life-threatening hemorrhage or hemorrhage requiring blood transfusion, endoscopy, or surgery within 3 months prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital & Institute
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
Y
Yanxi Pu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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