NCT07559019RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 24 Apr 2026
- Start date
- 21 May 2026
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07559019
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 150
- From 21 May 2026 to the primary completion date, 29 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the second affiliated hospital of AMU Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.