ASKB589 +CAPOX+Sintilimab/Tislelizumab: Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 6 cycles; Capecitabine: oral administration, 1000mg/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Sintilimab/Tislelizumab was administered intravenously at 200mg. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.
ASKB589 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy.
2. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment.
3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory
4. ECOG performance status 0-1.
5. The results of the laboratory tests must meet all criteria
6. Life expectancy of at least 3 months.
Exclusion Criteria:
1. Known active central nervous system metastasis or suspected cancerous meningitis;
2. There are moderate to large amounts of abdominal and pleural fluid.
3. The presence of clinically uncontrollable third interspace fluid；
4. Patients with any other malignant tumors within the past 5 years.
5. Applicable to anti-HER-2 drug therapy；
6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past；
7. Patients have received antitumor therapy during the first 4 weeks before study drug use;
8. 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;
Primary outcome measure(s)
Number of participants with adverse events as assessed by CTCAE v5.0 — up to 21 days following last dose An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period. — up to 21 days following last dose DLT is short for Dose Limiting Toxicity，dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Maximum Tolerated Dose (MTD） — up to 21 days following last dose The MTD was defined as the highest dose of ASKB589 not causing DLT in more than 33% of patients in the first treatment cycle.
The recommended dose — from date of treatment start until data cut-off, up to 2 years The recommended dose will be determined during the dose escalation and dose expansion stage of the study.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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