Small Cell Lung Cancer (SCLC)Phase 1NCT07559019
Safety and Preliminary Activity of BI115 in Advanced SCLC
A Phase 1 study testing IBI115 in people with Small Cell Lung Cancer (SCLC), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- IBI115
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 30 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of AMU
Chongqing, Chongqing Municipality, 400037
Bo Zhu, +86 023 6875 5114, bozhu_oncology@163.com
About this study
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
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
- Small Cell Lung Cancer (SCLC)
- Being tested
- IBI115
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI115Drug
IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| IBI115 | Experimental | 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. Receives: Drug: IBI115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE)
Safety Features including Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE).
Measured: up to 90 days after the last administration
Dose-limiting toxicity (DLT)
DLTs will be assessed during the DLT observation period to determine maximum tolerated dose (MTD) ) and/or recommended dose for combination (RDC).
Measured: up to 28 days after the first dose of IBI115
MTD of IBI115
to determine MTD of IBI115
Measured: up to 90 days after the last administration
RDC of IBI115
to determine RDC of IBI115
Measured: up to 90 days after the last administration
Number of participants with clinically significant changes in physical examination results
A complete physical examination will include: general appearance, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and pharynx), lymph nodes, thyroid, musculoskeletal (including spine and extremities), genital/anal, and neurological assessments, if indicated. Clinically significant abnormal findings at screening will be recorded as medical history or AE based on the investigator's analysis and judgment.
Measured: up to 90 days after the last administration
Number of participants with abnormal vital signs
Collection of vital signs will include body temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation.
Measured: up to 90 days after the last administration
Secondary outcomes (14)
Area under the concentration-time curve (AUC)
an element to assess the pharmacokinetics (PK) profile of IBI115
Measured: Up to 7 days after the last administration
Peak plasma concentration
an element to assess the PK profile of IBI115
Measured: Up to 7 days after the last administration
Time to peak concentration
an element to assess the PK profile of IBI115
Measured: Up to 7 days after the last administration
Clearance (CL)
an element to assess the PK profile of IBI115
Measured: Up to 7 days after the last administration
Apparent volume of distribution (V)
an element to assess the PK profile of IBI115
Measured: Up to 7 days after the last administration
Half-life (T1/2)
an element to assess the PK profile of IBI115
Measured: Up to 7 days after the last administration
Incidence of anti-drug antibodies (ADA)
an element to assess the immunogenicity profile of IBI115
Measured: Up to 7 days after the last administration
Incidence of neutralizing antibodies (NAb) (if applicable)
an element to assess the immunogenicity profile of IBI115
Measured: Up to 7 days after the last administration
Objective response rate (ORR)
based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through study completion, up to 2 years
Duration of response (DoR)
based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through study completion, up to 2 years
Tisease control rate (DCR)
based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through study completion, up to 2 years
Time to response (TTR)
based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through study completion, up to 2 years
Progression-free survival (PFS)
based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through study completion, up to 2 years
Overall survival (OS)
Overall survival (OS)
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start21 May 2026
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559019
- Sponsor's protocol ID
- CIBI115A101
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07559019
- Acronym / sponsor ID
- CIBI115A101
- Conditions
- Small Cell Lung Cancer (SCLC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI115 | Experimental | Drug: IBI115Subjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI115IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first. | Drug | IBI115 |
Primary outcome
Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE)
Time frame: up to 90 days after the last administration
Safety Features including Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE).
Dose-limiting toxicity (DLT)
Time frame: up to 28 days after the first dose of IBI115
DLTs will be assessed during the DLT observation period to determine maximum tolerated dose (MTD) ) and/or recommended dose for combination (RDC).
MTD of IBI115
Time frame: up to 90 days after the last administration
to determine MTD of IBI115
RDC of IBI115
Time frame: up to 90 days after the last administration
to determine RDC of IBI115
Number of participants with clinically significant changes in physical examination results
Time frame: up to 90 days after the last administration
A complete physical examination will include: general appearance, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and pharynx), lymph nodes, thyroid, musculoskeletal (including spine and extremities), genital/anal, and neurological assessments, if indicated. Clinically significant abnormal findings at screening will be recorded as medical history or AE based on the investigator's analysis and judgment.
Number of participants with abnormal vital signs
Time frame: up to 90 days after the last administration
Collection of vital signs will include body temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation.
14 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: Up to 7 days after the last administration
Peak plasma concentration
Time frame: Up to 7 days after the last administration
Time to peak concentration
Time frame: Up to 7 days after the last administration
Clearance (CL)
Time frame: Up to 7 days after the last administration
Apparent volume of distribution (V)
Time frame: Up to 7 days after the last administration
Half-life (T1/2)
Time frame: Up to 7 days after the last administration
Incidence of anti-drug antibodies (ADA)
Time frame: Up to 7 days after the last administration
Incidence of neutralizing antibodies (NAb) (if applicable)
Time frame: Up to 7 days after the last administration
Objective response rate (ORR)
Time frame: Through study completion, up to 2 years
Duration of response (DoR)
Time frame: Through study completion, up to 2 years
Tisease control rate (DCR)
Time frame: Through study completion, up to 2 years
Time to response (TTR)
Time frame: Through study completion, up to 2 years
Progression-free survival (PFS)
Time frame: Through study completion, up to 2 years
Overall survival (OS)
Time frame: Through study completion, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI115 in people with Small Cell Lung Cancer (SCLC), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Zhang (+86 021 3183 7200, kobe.zhang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE) (time frame: up to 90 days after the last administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.