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

NCT05632939 | Active Not Recruiting Phase 1

• 1 other identifier: ASK-LC-B589- Ib/II
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 PD-1 inhibitors in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.

Conditions

Gastric Cancer; Gastroesophageal Cancer (GC)

Keywords

CLDN18.2; gastric cancer; gastroesophageal cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (17)

• Pharmacokinetics:maximum Plasma Concentration [Cmax]

  Up to 21 days after injection

• Pharmacokinetics:time to maximum observed plasma concentration (Tmax)

  Up to 21 days after injection

• Pharmacokinetics:elimination rate constant（Kel）

  Up to 21 days after injection

• Pharmacokinetics:terminal elimination half life (T1/2)

  Up to 21 days after injection

• Pharmacokinetics:apparent volume of distribution (Vz/F)

  Up to 21 days after injection

Study Arms (1)

ASKB589 +CAPOX+Sintilimab/Tislelizumab

EXPERIMENTAL

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.

Drug: ASKB589 +CAPOX+Sintilimab/Tislelizumab

Interventions

ASKB589 +CAPOX+Sintilimab/Tislelizumab DRUG

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.

ASKB589 +CAPOX+Sintilimab/Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• AskGene Pharma, Inc.: lead
• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100089, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: February 21, 2023
• Primary Completion: October 31, 2025
• Study Completion: February 10, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)