Small Cell Lung CancerPhase 1NCT06613009
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
A Phase 1 study testing IBI3009 in people with Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- IBI3009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 Dec 2024to 30 Aug 2027
- 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 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;
- Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Minimum life expectancy of ≥ 12 weeks;
- Adequate organ function confirmed at screening period;
- Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC).
Who cannot join
- Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
- 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;
- Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
- 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.;
- Women who are pregnant, have positive results in pregnancy test or are lactating;
- Not eligible to participate in this study at the discretion of the investigator.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
China7 sites, 7 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
- Not yet recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250117
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Australia3 sites, 3 recruiting
- Recruiting
Austin Hospital
Heidelberg, Victoria, 3084
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Pei Ding, 0422 050 656, pei.ding@health.nsw.gov.au
- Not yet recruiting
Wollongong Hospital
Wollongong, New South Wales, 2500
About this study
Official title: A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
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
- Small Cell Lung Cancer
- Being tested
- IBI3009
- 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.
IBI3009Drug
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
| Study group | Role | What they receive |
|---|---|---|
| IBI3009 | Experimental | Not described Receives: Drug: IBI3009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of subjects with adverse events
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
Measured: Up to 3 years
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in electrocardiogram
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Measured: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
Measured: Up to 28 days
Secondary outcomes (12)
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3009
Measured: Up to 3 years
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3009
Measured: Up to 3 years
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3009
Measured: Up to 3 years
clearance (CL)
clearance (CL) of single and multiple doses of IBI3009
Measured: Up to 3 years
apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3009
Measured: Up to 3 years
half-life (t1/2)
half-life (t1/2) of IBI3009 to the last administration of IBI3009
Measured: Up to 3 years
anti-drug antibody (ADA)
Incidence and characterization of anti-drug antibody (ADA).
Measured: Up to 3 years
objective response rate (ORR)
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
duration of response (DoR)
duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
time to response (TTR)
time to response (TTR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
progression free survival (PFS)
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
overall survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Measured: Through out the study (an average of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start30 Dec 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (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 CancerStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 190 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
- NCT06613009
- Sponsor's protocol ID
- CIBI3009A101
- Status last verified
- Feb 2025
- First submitted
- 22 Sep 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06613009
- Acronym / sponsor ID
- CIBI3009A101
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 25 Sep 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI3009 | Experimental | Drug: IBI3009 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Minimum life expectancy of ≥ 12 weeks;
- Adequate organ function confirmed at screening period;
Key exclusion criteria (6 listed)
- Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
- 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;
- Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
- 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.;
- Women who are pregnant, have positive results in pregnancy test or are lactating;
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 |
|---|---|---|
| IBI3009Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009) | Drug | IBI3009 |
Primary outcome
Numbers of subjects with adverse events
Time frame: Up to 3 years
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
Number of subjects with clinically significant changes in physical examination results
Time frame: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram
Time frame: Up to 3 years
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Dose limiting toxicities (DLTs)
Time frame: Up to 28 days
Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
12 secondary outcomes
area under the curve (AUC)
Time frame: Up to 3 years
maximum concentration (Cmax)
Time frame: Up to 3 years
time to maximum concentration (Tmax)
Time frame: Up to 3 years
clearance (CL)
Time frame: Up to 3 years
apparent volume of distribution (V)
Time frame: Up to 3 years
half-life (t1/2)
Time frame: Up to 3 years
anti-drug antibody (ADA)
Time frame: Up to 3 years
objective response rate (ORR)
Time frame: Up to 3 years
duration of response (DoR)
Time frame: Up to 3 years
time to response (TTR)
Time frame: Up to 3 years
progression free survival (PFS)
Time frame: Up to 3 years
overall survival (OS)
Time frame: Through out the study (an average of 3 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 11 Feb 2025.
- Individual participant dataSharing planned: No
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3009 in people with Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 10 sites in 2 countries.
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 6 inclusion and 6 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Australia. 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 Lue Shen (+86 18507159591, lue.shen@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of subjects with adverse events (time frame: Up to 3 years). The study lists 5 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 11 Feb 2025.