NCT07559019 Safety and Preliminary Activity of BI115 in Advanced SCLC
| NCT ID | NCT07559019 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Small Cell Lung Cancer (SCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2026-05-21 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria： 1. 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. 2. Male or female participants aged ≥18 years and ≤75 years. 3. Participants with histologically or cytologically confirmed advanced small cell lung cancer. 4. At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 6. Expected survival period ≥12 weeks. 7. Adequate bone marrow and organ function confirmed during the screening period. Exclusion Criteria： 1. 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. 2. 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. 3. 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. 4. Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07559019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Small Cell Lung Cancer (SCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07559019 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07559019 currently recruiting?
Yes, NCT07559019 is actively recruiting participants. Contact the research team at kobe.zhang@innoventbio.com for enrollment information.
Where is the NCT07559019 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07559019 clinical trial?
NCT07559019 is sponsored by Innovent Biologics (Suzhou) Co. Ltd.. The trial plans to enroll 150 participants.
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