Actively Recruiting
Study of IBI3005 to Assess Safety and Dose in Advanced Malignant Solid Tumors An Open-label Phase 1 Trial Evaluating IBI3005 in 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
This research aims to evaluate the safety and tolerability of the drug IBI3005 in patients with unresectable, locally advanced, or metastatic solid tumors. The study also seeks to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IBI3005. It is a Phase Ia/Ib, open-label, multicenter trial focused on patients who have previously received third-generation EGFR tyrosine kinase inhibitors (TKIs) and experienced disease progression, including those with specific genetic mutations requiring targeted therapy. Participants will receive the investigational drug IBI3005, which is a bispecific monoclonal antibody conjugated with a camptothecin derivative. The treatment is administered by injection, and dosing will be carefully monitored to establish safety and optimal dosage. The study involves dose escalation to identify dose limiting toxicities (DLTs) over the first four weeks. Further treatment and follow-up will continue for up to three years to assess longer-term safety. Throughout the study, participants will undergo regular physical exams, vital sign measurements, and monitoring for adverse events. Researchers will track clinically significant changes and evaluate the drug's pharmacokinetics and preliminary effectiveness. Safety assessments include tracking adverse events and toxicities over the course of up to three years, ensuring close observation during and after treatment.
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
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital & Institute
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
Y
Yanxi Pu
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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