IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
1.Participants 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;
2.Male or female participants ≥ 18 years old;
3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4.Anticipated life expectancy of ≥ 12 weeks;
Disqualifiers
1.Drugs and other treatments to be excluded;
2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;
3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.
4.Allergic or hypersensitive to other monoclonal antibodies and/or Camptothecin Derivative based therapy, or any ingredients of IBI3014;
Trial design
Treatments tested in this trial
- IBI3014
- IBI3014
- IBI3014
- IBI3014
- IBI3014
- IBI3014
- IBI3014
- IBI3014
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov