NCT06170190

A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours

A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).

Conditions

• Locally Advanced Unresectable or Metastatic Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	IBI133	IBI133: The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the course of the study. Q3W

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-02-19
• Completion: 2025-02-19
• First posted: 2023-12-14
• Last updated: 2025-11-17

Locations

1 site across 1 country: Australia