Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGIBI3009
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3009)
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
| Dose limiting toxicities (DLTs) | Up to 28 days | Dose limiting toxicities (DLTs) to establish MTD and/or RDE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| area under the curve (AUC) | Up to 3 years | area under the curve (AUC) of single and multiple doses of IBI3009 |
| 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. |
| duration of response (DoR) | Up to 3 years | duration of response (DoR) as evaluated per the RECIST v1.1 criteria. |
| 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 |
Countries
Australia, China
Contacts
Primary ContactLue Shen
Outcome results
None listed