NCT07589205
Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
Recruiting · Phase 1 · Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · registry updated 2026-07-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
Inclusion
- 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;
- ECOG PS（Eastern Cooperative Oncology Group Performance Status）score of 0-1;
- Anticipated life expectancy of ≥ 12 weeks;
Exclusion
- Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional study;
- Prior anti-tumor therapy:
- Participants who have received cytotoxic therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first administration of study intervention ; Participants who have received PD-1/PD-L1 therapy within 4 weeks prior to the first administration of study drug; Participants who have received treatment with small molecule targeted therapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of the study drug; Palliative radiation therapy within 2 weeks or radical radiation therapy within 4 weeks prior to the first dose of study drug; Participants who had received adoptive cell therapy within 8 weeks prior to the first administration of study intervention.
- 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);