Clinical trial · Interventional
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
NCT07559019CI-TRIAL-00113714recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer (SCLC) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI115 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI115
- description
- Subjects will receive IBI115 therapy until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of treatment with IBI115 is 24M.
- interventionNames
- Drug: IBI115
Primary outcomes (6)
- measure
- Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE)
- timeFrame
- up to 90 days after the last administration
- description
- Safety Features including Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE).
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.