Clinical trial · Interventional
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
NCT06613009CI-TRIAL-00085789recruitingPhase 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)
The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.
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 | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI3009 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI3009
- interventionNames
- Drug: IBI3009
Primary outcomes (5)
- measure
- Numbers of subjects with adverse events
- timeFrame
- Up to 3 years
- description
- defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
- measure
- Number of subjects with clinically significant changes in physical examination results
- timeFrame
- Up to 3 years
- description
- Clinically significant abnormal physical examination findings reported by the investigator.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1; 4. Minimum life expectancy of ≥ 12 weeks; 5. Adequate organ function confirmed at screening period; 6. Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC). Exclusion Criteria 1. Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study; 2. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) prior to the first dose of the study drug; 3. Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients; 4. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.; 5. Women who are pregnant, have positive results in pregnancy test or are lactating; 6. Not eligible to participate in this study at the discretion of the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.