Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors (NCT07589205) | Clinical Trial Compass
RecruitingPhase 1
Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
China493 participantsStarted 2026-03-31
Plain-language summary
This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Adequate bone marrow and organ function as evidenced by :
. Hematological function: ANC(Absolute neutrophil count) ≥ 1.5 × 10 9 /L; platelet count (PLT) ≥ 90 × 10 9 /L; hemoglobin ≥ 9.0 g/dL, and without receiving granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), thrombopoietin (TPO), interleukin-11, or other leukocyte/platelet stimulating growth factors (including red blood cell and platelet transfusions) within at least 7 days before the first dose of the study drug;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numbers of subjects with adverse events
Timeframe: Up to 3 years
2
Numbers of subjects with serious adverse events
Timeframe: Up to 3 years
3
Number of subjects with clinically significant changes in laboratory parameters
Timeframe: Up to 3 years
4
Number of subjects with clinically significant changes in electrocardiogram
Timeframe: Up to 3 years
5
Number of subjects with clinically significant changes in vital signs
Timeframe: Up to 3 years
6
Number of subjects with clinically significant changes in physical examination results
Timeframe: Up to 3 years
7
Number of AEs（adverse events） leading to dose interruption
. 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:
. 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);
. Known allergies, hypersensitivity, or intolerance to IBI3028 or its excipients (refer to the Investigator's Brochure);
. Have undergone major surgery (craniotomy, thoracotomy, or laparotomy, and other surgeries according to Investigators' opinion, excluding needle biopsy) within 4 weeks prior to the first dose of the investigational product, or are expected to undergo major surgery during the study, or have severe unhealed wounds, ulcers, etc.;
. Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (ie, no neurologic syndrome and metastases ≤1.5 cm in diameter) or stable disease after treatment as judged by the investigator may be considered if: they have no metastases in the midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord; stable status for at least 4 weeks prior to the first dose of study drug (≤1.5 mg/day dexamethasone or equivalent and baseline anticonvulsants are allowed), and have no new or enlarging CNS metastases as clearly demonstrated by clinical evidence; Note : CNS lesions are not considered target lesions.
Number of AEs leading to dose delay
Timeframe: Up to 3 years
9
Number of AEs leading to dose reduction
Timeframe: Up to 3 years
10
Number of AEs leading to permanent discontinuation