Actively Recruiting
Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-06-04
150
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of IBI115, alone and combined with other therapies, in participants who have advanced small cell lung cancer. This is an open-label, Phase I study conducted across multiple regions to better understand how this treatment behaves in real patients with this condition. The study aims to monitor various side effects and determine appropriate dosing levels while observing participants' responses to the therapy. Participants will receive IBI115 treatment continuously until disease returns, side effects become unacceptable, a new anti-cancer treatment starts, withdrawal of consent, loss to follow-up, death, or other reasons requiring stopping treatment. The maximum treatment duration allowed is 24 months. The study includes an initial period to observe dose-limiting toxicities lasting 21 to 28 days after the first dose. Treatment continues beyond this period as long as it is safe and effective within the study timeline. During the study, participants will undergo regular assessments to track adverse events, physical exams, and vital signs up to 90 days after the last dose. Researchers will also measure drug concentrations and immune response markers within the week after treatment ends. Long-term outcomes such as response rate, duration of response, disease control, progression-free survival, and overall survival will be followed for up to two years. This comprehensive monitoring aims to capture the full impact of IBI115 therapy on advanced small cell lung cancer over time.
CONDITIONS
Brief Title
Safety and Preliminary Activity of BI115 in Advanced SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign written informed consent for all study procedures
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed advanced small cell lung cancer
- At least one measurable lesion by RECIST V1.1 within 28 days prior to first IBI115 dose
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate bone marrow and organ function confirmed at screening
You will not qualify if you...
- Participating concurrently in another interventional clinical study (excluding observational or survival follow-up phases)
- Received live vaccine within 4 weeks or cancer vaccine within 3 months prior to first study drug dose, or plans to receive live vaccine during study
- Unresolved adverse reactions from prior anti-tumor therapy not at baseline or Grade 0-1 by first study drug dose
- Known hypersensitivity or intolerance to IBI115, sintilimab, or any excipients
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 IBI115 therapy. After an initial 21 to 28 day Dose Limiting Toxicity observation period, participants continue treatment until disease progression, unacceptable toxicity, start of new anti-tumor therapy, withdrawal of consent, or for a maximum of 24 months, whichever occurs first.
Visits occur throughout treatment as needed for dosing and safety monitoring
Duration - Up to 90 days after treatment ends
Participants are monitored for safety outcomes including adverse events and treatment emergent effects for up to 90 days after the last dose of IBI115.
Approximately 1 to 3 follow-up visits
Trial Site Locations
Total: 1 location
1
the second affiliated hospital of AMU
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
Research Team
X
Xiao Zhang
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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