Under construction – not a live service
Sign in
Taking people in ChinaPhase 1

IBI115 for Advanced Small Cell Lung Cancer, Alone and With Other Treatment

Tests IBI115 in adults with advanced small cell lung cancer.

Key facts

Who runs it
Innovent Biologics (Suzhou) Co. Ltd.
Where
Chongqing, ChinaSee the site
Trial code
Registry title
Safety and Preliminary Activity of BI115 in Advanced SCLC
Status
Recruiting
Phase
Phase 1
People taking part
150 people, planned
Started
21 May 2026
Expected to end
30 Mar 2030
Type of study
Interventional
Treatments tested
  • IBI115
Record updated
4 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with advanced small cell lung cancer, to test the safety and effect of IBI115 alone and with other treatment.

Age
18 to 75 years.
Sex
Men and women can join.
Disease stage
Advanced small cell lung cancer confirmed by tissue or cell tests. At least one tumour that can be measured (RECIST V1.1) in the 28 days before the first dose of IBI115.
Earlier treatment
Side effects from earlier cancer treatment must have gone away or be at grade 0 or 1 (CTCAE v6.0) or at baseline level before the first dose. No live vaccine in the 4 weeks before the first dose, and no cancer vaccine in the 3 months before.

Main reasons for not taking part

  • Taking part in another interventional clinical study at the same time
  • Live vaccine in the 4 weeks before the first dose, or cancer vaccine in the 3 months before
  • Planning to receive a live vaccine during the study
  • Side effects from earlier cancer treatment that have not gone away
  • Known allergy or intolerance to IBI115, sintilimab or their other ingredients

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • the second affiliated hospital of AMUChongqing, ChinaContact: Bo ZhuTaking people

About the trial

What the trial wants to find out

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

The group in the trial

  • IBI115Treatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
IBI115 for Advanced Small Cell Lung Cancer, Alone and With Other TreatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07559019, who can take part
Record updated
4 June 2026