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Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.

• Male or female participants aged ≥18 years and ≤75 years.

• Participants with histologically or cytologically confirmed advanced small cell lung cancer.

• At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

• Expected survival period ≥12 weeks.

• Adequate bone marrow and organ function confirmed during the screening period.

Locations
Other Locations
China
the second affiliated hospital of AMU
RECRUITING
Chongqing
Contact Information
Primary
Xiao Zhang
kobe.zhang@innoventbio.com
+86 021 3183 7200
Time Frame
Start Date: 2026-05-21
Estimated Completion Date: 2030-03-30
Participants
Target number of participants: 150
Treatments
Experimental: IBI115
Subjects will receive IBI115 therapy until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of treatment with IBI115 is 24M.
Sponsors
Leads: Innovent Biologics (Suzhou) Co. Ltd.

This content was sourced from clinicaltrials.gov

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