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RecruitingNCT06613009Updated Feb 11, 2025

Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

A Phase 1 interventional study of IBI3009 in Small Cell Lung Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
190
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Small Cell Lung Cancer
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 190 is above the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 197 studies on the registry; 46 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Browse Innovent Biologics (Suzhou) Co. Ltd. studies →All Innovent Biologics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    IBI3009

    Drug: IBI3009

Interventions

  • DrugIBI3009

    Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 3 years

  2. Number of subjects with clinically significant changes in physical examination results

    Clinically significant abnormal physical examination findings reported by the investigator.

    Time frame: Up to 3 years

  3. Number of subjects with clinically significant changes in electrocardiogram

    Clinically significant abnormal electrocardiogram findings reported by the investigator.

    Time frame: Up to 3 years

  4. Number of subjects with clinically significant changes in vital signs

    Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

    Time frame: Up to 3 years

  5. Dose limiting toxicities (DLTs)

    Dose limiting toxicities (DLTs) to establish MTD and/or RDE.

    Time frame: Up to 28 days

Secondary outcomes

  1. area under the curve (AUC)

    area under the curve (AUC) of single and multiple doses of IBI3009

    Time frame: Up to 3 years

  2. maximum concentration (Cmax)

    maximum concentration (Cmax) of single and multiple doses of IBI3009

    Time frame: Up to 3 years

  3. time to maximum concentration (Tmax)

    time to maximum concentration (Tmax) of single and multiple doses of IBI3009

    Time frame: Up to 3 years

  4. clearance (CL)

    clearance (CL) of single and multiple doses of IBI3009

    Time frame: Up to 3 years

  5. apparent volume of distribution (V)

    apparent volume of distribution (V) of single and multiple doses of IBI3009

    Time frame: Up to 3 years

  6. half-life (t1/2)

    half-life (t1/2) of IBI3009 to the last administration of IBI3009

    Time frame: Up to 3 years

  7. anti-drug antibody (ADA)

    Incidence and characterization of anti-drug antibody (ADA).

    Time frame: Up to 3 years

  8. objective response rate (ORR)

    objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.

    Time frame: Up to 3 years

  9. duration of response (DoR)

    duration of response (DoR) as evaluated per the RECIST v1.1 criteria.

    Time frame: Up to 3 years

  10. time to response (TTR)

    time to response (TTR) as evaluated per the RECIST v1.1 criteria.

    Time frame: Up to 3 years

  11. progression free survival (PFS)

    as evaluated per the RECIST v1.1 criteria.

    Time frame: Up to 3 years

  12. 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.

    Time frame: Through out the study (an average of 3 years)

07

Study locations

4 of 10 sites recruiting
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
    Recruiting
  • Wollongong Hospital
    Wollongong, New South Wales 2500, Australia
    Not yet recruiting
  • Austin Hospital
    Heidelberg, Victoria 3084, Australia
    Recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230022, China
    Not yet recruiting
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 350005, China
    Not yet recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450000, China
    Not yet recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan 410000, China
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    Not yet recruiting
  • Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
    Jinan, Shandong 250117, China
    Not yet recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310005, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06613009
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Sep 25, 2024
Start date
Dec 30, 2024
Primary completion
Aug 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Feb 11, 2025

Study contacts

Lue Shen
Contact
lue.shen@innoventbio.com
+86 18507159591

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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