Actively Recruiting
A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2023-11-29
182
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1/2 multicenter, open-label clinical trial to study IBI130 in patients with unresectable, locally advanced, or metastatic solid tumors. The study aims to find the maximum tolerated dose and recommended phase 2 dose of IBI130, and then explore its efficacy, safety, and tolerability in these patients. The trial plans to enroll between 20 and 182 subjects in phase 1 and about 150 evaluable subjects in phase 2. Participants will receive IBI130 until unacceptable side effects occur, the disease progresses, they withdraw consent, or for a maximum of 24 months, whichever happens first. The study includes a dose escalation and expansion phase in phase 1 to identify appropriate dosing, followed by a phase 2 period to evaluate treatment responses. There is no placebo group, and all participants receive IBI130. During the study, researchers will monitor adverse events up to 30 days after the last dose. They will also assess objective response rate, duration of response, and overall survival for up to 3 years following the first dose. Participants will undergo evaluations to track treatment effects and safety throughout their involvement. The total length of participation varies based on individual treatment duration and follow-up assessments.
CONDITIONS
Brief Title
A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and give written informed consent
- Male or female subjects 18 years old or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Anticipated life expectancy of 12 weeks or more
- Adequate bone marrow and organ function
You will not qualify if you...
- Currently enrolled in any other interventional clinical research except observational or follow-up studies
- Received previous anti-tumor therapy within 4 weeks or 5 half-lives before first study drug administration
- Planning to receive other antitumor therapy during the study except palliative radiotherapy for symptom relief without affecting tumor assessment
- Received live vaccines within 4 weeks prior to first study drug dose or planning to receive any live vaccine during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive IBI130 until unacceptable toxicity, disease progression, withdrawal of consent, or for up to 24 months, whichever occurs first.
Visits as needed for treatment administration and monitoring
Duration - 30 days
Participants are monitored for adverse events up to 30 days after the last dose of treatment.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Sunshine Coast University
Birtinya, Queensland, Australia, 4575
Actively Recruiting
Research Team
S
Serena Dong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here