Spots Global Cancer Trial Database for A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Official Title: A Phase 1/2, Multicenter, Open-label Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Study ID: NCT06198426
Conditions
Interventions
Study Description
Brief Summary: This is an open-label, multicenter, dose escalation and expansion phase I /II study of IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size is 46. One or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Scientia Clinical Research Ltd, Randwick, New South Wales, Australia
Contact Details
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