IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (NCT07483554) | Clinical Trial Compass
RecruitingPhase 2
IBI343 in Combination Therapy for Advanced Malignant Solid Tumors
China389 participantsStarted 2026-04-20
Plain-language summary
A Phase II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IBI343 in combination therapy for patients with advanced malignant solid tumors.To evaluate the efficacy and safety of IBI343 in combination therapy for patients with advanced malignant solid tumors.Enrollment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma positive for CLDN18.2, and subjects with pancreatic ductal adenocarcinoma positive for CLDN18.2.
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
. Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures.
. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
. Age ≥ 18 years, no gender restrictions.
. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
. Expected survival ≥ 12 weeks.
. Adequate bone marrow and organ function.
. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the end of treatment.
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
Objective Response Rate (ORR) evaluated according to RECIST v1.1
Timeframe: Up to 24 months
2
Incidence of Adverse Events (AE)
Timeframe: Up to 24 months
3
Incidence of treatment-emergent adverse Events (TEAE)
Timeframe: Up to 24 months
4
Incidence of adverse events of Special Interest (AESI)
Timeframe: Up to 24 months
5
Incidence of serious adverse events (SAE)
Timeframe: Up to 24 months
6
Number of participants with abnormal laboratory tests results
Timeframe: Up to 24 months
7
Number of subjects with clinically significant changes in physical examination results
. Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.
Exclusion criteria
. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
. Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug.
. Received the last anti-tumor treatment within 4 weeks or 5 half-lives of the anti-tumor therapy (whichever is shorter) before the first dose of the investigational drug.
. Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.
. Underwent biliary stent placement within 7 days prior to the first dose of the investigational drug.
. Planning to receive other anti-tumor treatments during the period of treatment with the investigational drug.
. Received any live vaccine within 4 weeks prior to the first dose of the investigational drug or planning to receive any live vaccine during the study.
. Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has unhealed wounds, ulcers, or fractures; or plans to undergo major surgery during the study.
Number of subjects with clinically significant changes in vital signs