Study of IBI3009 in Subjects With Unresectable, Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06613009
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Innovent Biologics (Suzhou) Co. Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

Arms & Interventions

Arms

Experimental: IBI3009

Interventions

Drug: - IBI3009

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Westmead Hospital, Westmead, New South Wales, Australia

Status

Address

Westmead Hospital

Westmead, New South Wales, 2145

Site Contact

Pei Ding

[email protected]

0422 050 656

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