Clinical trial NCT05632939: ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer.
Official title: A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Lead sponsor: AskGene Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First posted: 2022-12-01
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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;

Primary outcomes:
measure: Number of participants with adverse events as assessed by CTCAE v5.0
timeFrame: up to 21 days following last dose
measure: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period.
timeFrame: up to 21 days following last dose
measure: Maximum Tolerated Dose (MTD）
timeFrame: up to 21 days following last dose
measure: The recommended dose
timeFrame: from date of treatment start until data cut-off, up to 2 years
Secondary outcomes:
measure: Pharmacokinetics:maximum Plasma Concentration [Cmax]
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics:time to maximum observed plasma concentration (Tmax)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics:elimination rate constant（Kel）
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics:terminal elimination half life (T1/2)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics:apparent volume of distribution (Vz/F)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics:Area Under Curve (AUC)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics: Mean ResidenceTime（MRT）
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics: plasma clearance rate (CL)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics: steady-state peak concentration (Css_max)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics: time to steady-state peak concentration (Tss_max)
timeFrame: Up to 21 days after injection
measure: Pharmacokinetics: minimum value of steady plasma drug concentration（Css_min）
timeFrame: Up to 21 days after injection
measure: Evaluation of immunogenicity
timeFrame: from date of treatment start until data cut-off, up to 2 years
measure: Objective response rate（ORR）
timeFrame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
measure: disease control rate（DCR)
timeFrame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
measure: Duration of Response（DOR）
timeFrame: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
measure: Progression free survival（PFS）
timeFrame: from date of treatment start until the date of disease progression or until death due to any causes, up to 2 years
measure: Overall survival（OS）
timeFrame: from the date of treatment start until the documented date of death from any cause，up to 2 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: