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NCT Number: NCT06206733

ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing cancer hospital

Beijing, China

About this study

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

This study will also evaluate efficacy, physical function, safety, and tolerability of ASKB589, as well as its effects on quality of life. Pharmacokinetics (PK) of ASKB589 and the immunogenicity profile of ASKB589 will be evaluated as well.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction
  • Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization
  • Suitable for chemotherapy combined with PD-1 inhibitor
  • Not suitable for anti-HER2 therapy
  • Have at least one measurable lesion according to RECIST1.1 assessed by site investigator within 28 days prior to randomization
  • CLDN 18.2 positive

Exclusion criteria

  • Patients with active central nervous system (CNS) metastases or suspected carcinomatous meningitis
  • Participants have significant gastric bleeding
  • The presence of clinically uncontrollable third interspace fluid
  • Received anti-CLDN18.2 antibody at any time in the past
  • Suspected complete or partial obstruction of gastroesophageal access

Treatment and study plan

ASKB589

Drug

ASKB589 will be administered as a minimum 3-hour IV infusion

Oxaliplatin

Drug

Oxaliplatin will be administered as a minimum 2-hour IV infusion

Capecitabine

Drug

Capecitabine will be administered orally twice daily (bid).

Tislelizumab

Drug

Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

Placebo

Drug

Placebo will be administered as a minimum 3-hour IV infusion

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Until disease progression or withdrawal from the study (generally up to 24 months)

    PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Until death or withdrawal from the study

    OS is defined as the time from the date of randomization until the date of death from any cause.

Other outcomes

  1. Objective Response Rate (ORR)

    Time frame: Until disease progression or withdrawal from the study (generally up to 24 months)

    ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by Independent Review Committee (IRC) per RECIST 1.1.

  2. Duration Of Response (DOR)

    Time frame: Until disease progression or withdrawal from the study (generally up to 24 months)

    DOR, defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.

  3. Safety and tolerability assessed by adverse events (AEs)

    Time frame: Until 90 days after the end of treatment

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  4. Number of participants with laboratory assessments abnormalities

    Time frame: Until the end of treatment (generally up to 24 months)

    Number of participants with potentially clinically significant laboratory values.

  5. Number of participants with vital signs abnormalities and/or adverse events

    Time frame: Until 90 days after the end of treatment

    Number of participants with potentially clinically significant vital sign values.

  6. Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)

    Time frame: Until the end of treatment (generally up to 24 months)

    EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change

  7. Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire

    Time frame: Until the end of treatment (generally up to 24 months)

    The GP instrument is a single assessment of overall pain where 0 equals no pain and 10 equals extreme pain. Low pain scores are considered a better outcome than a high pain score

  8. Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire

    Time frame: Until the end of treatment (generally up to 24 months)

    The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.

  9. Pharmacokinetics (PK) of ASKB589

    Time frame: up to 6 cycles (21 days for 1 cycle)

    Ctrough will be derived from the PK serum samples collected.

  10. Number of anti-drug antibody (ADA) Positive Participants

    Time frame: up to 6 cycles (21 days for 1 cycle)

    Immunogenicity will be measured by the number of participants that are ADA positive.

Sponsors and collaborators

Lead sponsor

AskGene Pharma, Inc.

Industry

Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase III Study Evaluating the Efficacy and Safety of ASKB589 Combined With CAPOX and PD-1 Inhibitor as First-Line Treatment in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 16, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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