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

Phase 1

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: IBI3009

• Registration Number: NCT06613009
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Study First Posted: 2024-09-25
• Study Start: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IBI3009	IBI3009	-

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLTs)	Up to 28 days	Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
Number of subjects with clinically significant changes in physical examination results	Up to 3 years	Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram	Up to 3 years	Clinically significant abnormal electrocardiogram findings reported by the investigator.
Numbers of subjects with adverse events	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 vital signs	Up to 3 years	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

Secondary Outcome Measures

Name	Time	Method
area under the curve (AUC)	Up to 3 years	area under the curve (AUC) of single and multiple doses of IBI3009
maximum concentration (Cmax)	Up to 3 years	maximum concentration (Cmax) of single and multiple doses of IBI3009
time to maximum concentration (Tmax)	Up to 3 years	time to maximum concentration (Tmax) of single and multiple doses of IBI3009
clearance (CL)	Up to 3 years	clearance (CL) of single and multiple doses of IBI3009
apparent volume of distribution (V)	Up to 3 years	apparent volume of distribution (V) of single and multiple doses of IBI3009
half-life (t1/2)	Up to 3 years	half-life (t1/2) of IBI3009 to the last administration of IBI3009
anti-drug antibody (ADA)	Up to 3 years	Incidence and characterization of anti-drug antibody (ADA).
objective response rate (ORR)	Up to 3 years	objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
duration of response (DoR)	Up to 3 years	duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
time to response (TTR)	Up to 3 years	time to response (TTR) as evaluated per the RECIST v1.1 criteria.
progression free survival (PFS)	Up to 3 years	as evaluated per the RECIST v1.1 criteria.
overall survival (OS)	Through out the study (an average of 3 years)	OS is defined as the time from the date of first dose of study drug until the date of death from any cause.

Trial Locations

Locations (10)

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital); 🇨🇳 Jinan, Shandong, China

Wollongong Hospital; 🇦🇺 Wollongong, New South Wales, Australia

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China