The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
NCT Number: NCT05199519
A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Suzhou, Jiangsu, 215000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IBI345 CAR-T cell injection by intravenous infusion
Time frame: up to 2 years
Time frame: up to 2 years
Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Time frame: up to 2 years
Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Defined as the proportion of subjects who have achieved CR, PR, or stable disease (duration of stable disease should be ≥3 months).
Time frame: up to 2 years
Defined as the time from first dose to first documentation of objective response (either CR or PR).
Time frame: up to 2 years
Defined as the time from first dose to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Defined as the time from first dose to the date of death due to any cause.
Time frame: up to 1 years
Time frame: up to 1 years
Time frame: up to 1 years
Time frame: up to 1 years
Time frame: up to 1 years
Time frame: up to 1 years
Time frame: up to 1 years
Time frame: up to 1 years
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 in Patients With CLDN18.2-positive Solid Tumors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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CLDN18.2 Positive Solid Tumors
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