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

NCT06613009 | Recruiting Phase 1

• 1 other identifier: CIBI3009A101
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 10

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• area under the curve (AUC)

  Up to 3 years

• maximum concentration (Cmax)

  Up to 3 years

• time to maximum concentration (Tmax)

  Up to 3 years

• clearance (CL)

  Up to 3 years

• apparent volume of distribution (V)

  Up to 3 years

Study Arms (1)

IBI3009

EXPERIMENTAL

Drug: IBI3009

Interventions

IBI3009 DRUG

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

IBI3009

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

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

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Lue Shen

CONTACT

+86 18507159591; lue.shen@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7); AU (3)