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Trial Title:
ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer.
NCT ID:
NCT05632939
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ASKB589 +CAPOX+Sintilimab
Description:
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 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.
Arm group label:
ASKB589 +CAPOX+Sintilimab
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
Sintilimab in first-line treatment of patients with locally advanced, recurrent, or
metastatic gastric and esophagogastric junction adenocarcinoma.
Detailed description:
A two-part, dose-escalation and expansion study of ASKB589 was initiated to determine the
MTD, PK, PD, and efficacy in combination with chemotherapy and Sintilimab.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100089
Country:
China
Status:
Recruiting
Start date:
February 10, 2023
Completion date:
February 10, 2026
Lead sponsor:
Agency:
AskGene Pharma, Inc.
Agency class:
Industry
Collaborator:
Agency:
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
AskGene Pharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05632939
