A Phase 1 study of IBI3009 in Participants with ES-SCLC
Research type
Research Study
Full title
A Phase I Multicenter, Open-Label Study of IBI3009 as Monotherapy, or in Combination with Other Anti-Cancer Therapies in Participants with Extensive-Stage Small Cell Lung Cancer
IRAS ID
1013384
Contact name
Sujie Zhang
Contact email
Sponsor organisation
Innovent Biologics (Suzhou) Co., Ltd
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to see how safe and well tolerated IBI3009 is for people with ES-SCLC, by monitoring the number and seriousness of side effects in participants. This study will also help researchers learn how the body processes the medicine (pharmacokinetics) and whether it demonstrates evidence of controlling cancer growth. They will also find out how the body’s immune system reacts to IBI3009 by measuring how many participants develop antibodies (proteins made by the immune system) against IBI3009. The study doctors will also try to find the safest and most effective dose of IBI3009 for people with ES-SCLC. A total of up to 290 participants from China, Australia, and the United States will take part in this study. This is an open-label study, which means both participants and study doctors will know which treatment is being given. All participants in this study will receive active treatment with IBI3009 (alone or in combination with other anti-cancer medicines). The study will be conducted in several parts:
Part 1 (Dose Escalation, up to 170 participants): The first set of participants will receive a low dose of IBI3009 to see if this dose is safe for participants. If no medical problems occur, another set of participants will receive the next higher dose and so forth until the highest safe dose(s) is found.
Part 2 (Dose Expansion, about 80 participants): Participants will receive IBI3009 alone at the selected dose levels to learn more about how well it works and to confirm safety.
Part 3 (Combination Therapy, 20 to 40 participants): Participants will receive IBI3009 with atezolizumab (Tecentriq®) to see whether the combination is safe and helps control cancer. This study will be conducted in the following 3 periods.REC name
London - Chelsea Research Ethics Committee
REC reference
26/LO/0095
Date of REC Opinion
13 Apr 2026
REC opinion
Further Information Favourable Opinion