IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

NCT 06349408

Brief Summary

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Intervention / Treatment 

  • Drug: IBI3001

Inclusion Criteria:

  1. Male or female participants ≥ 18 years old;
  2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  3. Has an anticipated life expectancy of ≥ 12 weeks;
  4. Adequate bone marrow and organ function:
  5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
  6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Keep up with Rare Cancers Australia

Inside Rare is a monthly newsletter that shares the latest news, events and stories connecting the rare community.