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Trial Title:
Study of IBI3009 in Subjects With Unresectable, Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
NCT ID:
NCT06613009
Condition:
Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI3009
Description:
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3009)
Arm group label:
IBI3009
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 Phase 2 Dose (RP2D)
of IBI3009.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects with 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. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function confirmed at screening period;
6. Histologically or cytologically confirmed unresectable, locally advanced or
metastatic small cell lung cancer (SCLC), large cell neuroendocrine lung cancer
(lung LCNEC),neuroendocrine prostate cancer (NEPC), and other extra-pulmonary
neuroendocrine carcinomas;
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) or baseline 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Contact:
Last name:
Pei Ding
Phone:
0422 050 656
Email:
pei.ding@health.nsw.gov.au
Start date:
September 30, 2024
Completion date:
August 30, 2027
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613009
