Safety and Preliminary Activity of BI115 in Advanced SCLC
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
Innovent Biologics (Suzhou) Co. Ltd.
150 participants
May 21, 2026
INTERVENTIONAL
Conditions
Summary
This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer
Eligibility
Inclusion Criteria7
- Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.
- Male or female participants aged ≥18 years and ≤75 years.
- Participants with histologically or cytologically confirmed advanced small cell lung cancer.
- At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected survival period ≥12 weeks.
- Adequate bone marrow and organ function confirmed during the screening period.
Exclusion Criteria4
- Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study.
- Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period.
- Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug.
- Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.
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Interventions
IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07559019