Clinical trial NCT06206733: ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
Keywords: CLDN 18.2
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
ASKB589
Lead sponsor: AskGene Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First posted: 2024-01-16
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 18 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 24 months
Other outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 18 months
measure: Duration Of Response (DOR)
timeFrame: up to 18 months
measure: Safety and tolerability assessed by adverse events (AEs)
timeFrame: up to 18 months
measure: Number of participants with laboratory assessments abnormalities and or adverse events
timeFrame: up to 18 months
measure: Number of participants with vital signs abnormalities and or adverse events
timeFrame: up to 18 months
measure: 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)
timeFrame: up to 18 months
measure: Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire
timeFrame: up to 18 months
measure: Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
timeFrame: up to 18 months
measure: Pharmacokinetics (PK) of ASKB589
timeFrame: up to 18 months
measure: Number of anti-drug antibody (ADA) Positive Participants
timeFrame: up to 18 months
Locations:
city: Beijing
country: China
facility: Beijing cancer hospital
Study officials:
References: