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 range18 Years
SexALL
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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
✕. 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;
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
✕. 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;