New drug IBI115 enters human testing for tough lung cancer
NCT ID NCT07559019
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new drug called IBI115, alone or with other treatments, in 150 people with advanced small cell lung cancer. The main goals are to check safety, find the right dose, and look for early signs that the drug might help control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI115
- What this could lead to
- If it works, this could point toward a new treatment option for advanced small cell lung cancer.
- What could go wrong
- This is a very early Phase 1 trial with only 150 people. The main goal is safety, not proof of effectiveness. Many drugs fail at this stage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Mar 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Small cell lung cancer ( SCLC ) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
the second affiliated hospital of AMU
RECRUITINGChongqing, Chongqing Municipality, 400037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A deep dive into tumor markers could personalize lung cancer care
- Can armored CAR t cells take down Hard-to-Treat neuroendocrine cancers?
- Engineered immune cells take aim at stubborn lung cancer
- Could a hidden nerve condition be more common in lung cancer than we think?
- Can a gentler drug trio tame small cell lung cancer in older patients?
- Experimental combo aims to tackle Treatment-Resistant cancers