Status:
COMPLETED
A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Locally Advanced Unresectable or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 d...
Eligibility Criteria
Inclusion
- Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function.
- Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
Exclusion
- Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
- Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.
- Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06170190
Start Date
January 16 2024
End Date
February 19 2025
Last Update
November 17 2025
Active Locations (1)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170