ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.

Phase 2Active Not RecruitingNCT05632939

AskGene Pharma, Inc.62 enrolled

Overview

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.

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 PD-1 inhibitors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer Gastroesophageal Cancer (GC)

Interventions

ASKB589 +CAPOX+Sintilimab/TislelizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Number of participants with adverse events as assessed by CTCAE v5.0

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.

Time frame: up to 21 days following last dose

The incidence and case number of DLT (Dose Limiting Toxicity) during observation period.

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.

Time frame: up to 21 days following last dose

Maximum Tolerated Dose (MTD）

The MTD was defined as the highest dose of ASKB589 not causing DLT in more than 33% of patients in the first treatment cycle.

Time frame: up to 21 days following last dose

The recommended dose

The recommended dose will be determined during the dose escalation and dose expansion stage of the study.

Time frame: from date of treatment start until data cut-off, up to 2 years

Secondary Outcomes

Pharmacokinetics:maximum Plasma Concentration [Cmax]

Serum samples will be collected for Cmax analysis.

Time frame: Up to 21 days after injection

Pharmacokinetics:time to maximum observed plasma concentration (Tmax)

Serum samples will be collected for Tmax analysis.

Time frame: Up to 21 days after injection

Pharmacokinetics:elimination rate constant（Kel）

Data from ClinicalTrials.gov

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