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

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.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: IBI3009

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lue Shen; Phone Number: +86 18507159591; Email: lue.shen@innoventbio.com

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Pei Ding; Phone Number: 0422 050 656; Email: pei.ding@health.nsw.gov.au
    • Wollongong, New South Wales, Australia, 2500
      • Not yet recruiting
      • Wollongong Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Hospital
• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Not yet recruiting
      • The First Affiliated Hospital of Anhui Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Not yet recruiting
      • The First Affiliated Hospital of Fujian Medical University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Not yet recruiting
      • The First Affiliated Hospital of Nanchang University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Not yet recruiting
      • Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Recruiting
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI3009	Drug: IBI3009; Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3009)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to 3 years
Number of subjects with clinically significant changes in electrocardiogram	Clinically significant abnormal electrocardiogram findings reported by the investigator.	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	Up to 3 years
Dose limiting toxicities (DLTs)	Dose limiting toxicities (DLTs) to establish MTD and/or RDE.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
area under the curve (AUC)	area under the curve (AUC) of single and multiple doses of IBI3009	Up to 3 years
maximum concentration (Cmax)	maximum concentration (Cmax) of single and multiple doses of IBI3009	Up to 3 years
time to maximum concentration (Tmax)	time to maximum concentration (Tmax) of single and multiple doses of IBI3009	Up to 3 years
clearance (CL)	clearance (CL) of single and multiple doses of IBI3009	Up to 3 years
apparent volume of distribution (V)	apparent volume of distribution (V) of single and multiple doses of IBI3009	Up to 3 years
half-life (t1/2)	half-life (t1/2) of IBI3009 to the last administration of IBI3009	Up to 3 years
anti-drug antibody (ADA)	Incidence and characterization of anti-drug antibody (ADA).	Up to 3 years
objective response rate (ORR)	objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.	Up to 3 years
duration of response (DoR)	duration of response (DoR) as evaluated per the RECIST v1.1 criteria.	Up to 3 years
time to response (TTR)	time to response (TTR) as evaluated per the RECIST v1.1 criteria.	Up to 3 years
progression free survival (PFS)	as evaluated per the RECIST v1.1 criteria.	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.	Through out the study (an average of 3 years)

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CIBI3009A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No