ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable… (NCT05632939) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.
China62 participantsStarted 2023-02-21
Plain-language summary
This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and PD-1 inhibitors in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.
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
. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy.
. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment.
. Tumor tissue samples are CLDN18.2 positive detected by central laboratory
. ECOG performance status 0-1.
. The results of the laboratory tests must meet all criteria
. Life expectancy of at least 3 months.
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
Number of participants with adverse events as assessed by CTCAE v5.0
Timeframe: up to 21 days following last dose
2
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period.
Timeframe: up to 21 days following last dose
3
Maximum Tolerated Dose (MTD）
Timeframe: up to 21 days following last dose
4
The recommended dose
Timeframe: from date of treatment start until data cut-off, up to 2 years
. Known active central nervous system metastasis or suspected cancerous meningitis;
. There are moderate to large amounts of abdominal and pleural fluid.
. The presence of clinically uncontrollable third interspace fluid；
. Patients with any other malignant tumors within the past 5 years.
. Applicable to anti-HER-2 drug therapy；
. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past；
. Patients have received antitumor therapy during the first 4 weeks before study drug use;
. Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;