Recruiting NCT06613009
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI3009.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
Overview
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.
Interventions
- Drug IBI3009
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
Primary outcome measures
- Numbers of subjects with adverse events [Time frame: Up to 3 years]
- Number of subjects with clinically significant changes in physical examination results [Time frame: Up to 3 years]
- Number of subjects with clinically significant changes in electrocardiogram [Time frame: Up to 3 years]
- Number of subjects with clinically significant changes in vital signs [Time frame: Up to 3 years]
- Dose limiting toxicities (DLTs) [Time frame: Up to 28 days]
Secondary outcome measures (12)
- area under the curve (AUC) [Time frame: Up to 3 years]
- maximum concentration (Cmax) [Time frame: Up to 3 years]
- time to maximum concentration (Tmax) [Time frame: Up to 3 years]
- clearance (CL) [Time frame: Up to 3 years]
- apparent volume of distribution (V) [Time frame: Up to 3 years]
- half-life (t1/2) [Time frame: Up to 3 years]
- anti-drug antibody (ADA) [Time frame: Up to 3 years]
- objective response rate (ORR) [Time frame: Up to 3 years]
- duration of response (DoR) [Time frame: Up to 3 years]
- time to response (TTR) [Time frame: Up to 3 years]
- progression free survival (PFS) [Time frame: Up to 3 years]
- overall survival (OS) [Time frame: Through out the study (an average of 3 years)]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 7 centers
- The First Affiliated Hospital of Anhui Medical University — Hefei
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
- Henan Cancer Hospital — Zhengzhou
- Hunan Cancer Hospital — Changsha
- The First Affiliated Hospital of Nanchang University — Nanchang
- Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong C — Jinan
- Zhejiang Cancer Hospital — Hangzhou
Australia · 3 centers
- Westmead Hospital — Westmead
- Wollongong Hospital — Wollongong
- Austin Hospital — Heidelberg
Identifiers
NCT: NCT06613009 · CIBI3009A101