Phase 1 study for people with Lung Cancer

Recruiting Phase 1

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 1
Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Registry number NCT06613009
Started 30 December 2024 Today 16 October 2026 Estimated completion 30 August 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Westmead Hospital Westmead NSW Recruiting
Wollongong Hospital Wollongong NSW Not yet recruiting
Austin Hospital Heidelberg VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 75 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 190

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 30 December 2024
Estimated completion 30 August 2027
Registry last updated 11 February 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 11 February 2025.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.