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Clinical Trials in China / NCT06613009
Recruiting Phase 1

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

NCT06613009 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 1
Started
2024-12-30
Last updated
2025-02-11

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

IBI3009

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Westmead Hospital Westmead New South Wales Recruiting
Wollongong Hospital Wollongong New South Wales Not Yet Recruiting
Austin Hospital Heidelberg Victoria Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital) Jinan Shandong Not Yet Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06613009 on ClinicalTrials.gov ↗ ← All trials in China