Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

About this trial

This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors

Eligibility criteria

Qualifiers

Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this protocol;

Male or female participants aged 18 years or older;

Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;

Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose of IBI3028;

Disqualifiers

Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional study;

Have received live vaccines within 4 weeks or tumor vaccines within 3 months prior to the first administration of the study drug, or plan to receive any live vaccines during the study;

Use of strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitors within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug;

Adverse reactions caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 or baseline level according to NCI CTCAE v5.0 before the first dose of the study drug (except for alopecia, fatigue, pigmentation, and other conditions with no safety implications per the Investigator's clinical judgement);

Trial design

Treatments tested in this trial

  • Drug: IBI3028

Treatment groups

493 Participants
are divided into 1 treatment group