Sunshine Coast University
Birtinya, Queensland, 4575, Australia
Location status: Recruiting
NCT Number: NCT05923008
This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Birtinya, Queensland, 4575, Australia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive IBI130 until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
Time frame: Up to 30 days post last dose
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame: Time from first dose to best response to treatment, assessed up to 3 years
ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
Time frame: Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years
For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death
Time frame: Time from first dose to death, assessed up to 3 years
Time from the date of the first dose to death of the subject due to any cause
Contact information is provided by the study sponsor or research team.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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