Clinical trial NCT06613009: Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
Official title: A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-25
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Numbers of subjects with adverse events
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in physical examination results
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in electrocardiogram
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: Up to 3 years
measure: Dose limiting toxicities (DLTs)
timeFrame: Up to 28 days
Secondary outcomes:
measure: area under the curve (AUC)
timeFrame: Up to 3 years
measure: maximum concentration (Cmax)
timeFrame: Up to 3 years
measure: time to maximum concentration (Tmax)
timeFrame: Up to 3 years
measure: clearance (CL)
timeFrame: Up to 3 years
measure: apparent volume of distribution (V)
timeFrame: Up to 3 years
measure: half-life (t1/2)
timeFrame: Up to 3 years
measure: anti-drug antibody (ADA)
timeFrame: Up to 3 years
measure: objective response rate (ORR)
timeFrame: Up to 3 years
measure: duration of response (DoR)
timeFrame: Up to 3 years
measure: time to response (TTR)
timeFrame: Up to 3 years
measure: progression free survival (PFS)
timeFrame: Up to 3 years
measure: overall survival (OS)
timeFrame: Through out the study (an average of 3 years)
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
state: Shandong
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: