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

Gastric Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206733
• Other study ID #: ASK-LC-B589-III-1
• Status: Recruiting
• Phase: Phase 3
• Start date: January 25, 2024
• Est. completion date: December 30, 2028

Study information

• Verified date: March 2024
• Source: AskGene Pharma, Inc.
• Contact: Yuan Yangzhou
• Phone: 025-8509062
• Email: yuanyangzhou[@]ask-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
• ASKB589
ASKB589 will be administered as a minimum 3-hour IV infusion
• Oxaliplatin
Oxaliplatin will be administered as a minimum 2-hour IV infusion
• Capecitabine
Capecitabine will be administered orally twice daily (bid).
• Tislelizumab
Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
• Placebo
Placebo will be administered as a minimum 3-hour IV infusion

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
AskGene Pharma, Inc.	Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective Response Rate (ORR)	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.	up to 18 months
Other	Duration Of Response (DOR)	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.	up to 18 months
Other	Safety and tolerability assessed by adverse events (AEs)	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.	up to 18 months
Other	Number of participants with laboratory assessments abnormalities and or adverse events	Number of participants with potentially clinically significant laboratory values.	up to 18 months
Other	Number of participants with vital signs abnormalities and or adverse events	Number of participants with potentially clinically significant vital sign values.	up to 18 months
Other	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)	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	up to 18 months
Other	Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire	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	up to 18 months
Other	Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire	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.	up to 18 months
Other	Pharmacokinetics (PK) of ASKB589	Ctrough will be derived from the PK serum samples collected.	up to 18 months
Other	Number of anti-drug antibody (ADA) Positive Participants	Immunogenicity will be measured by the number of participants that are ADA positive.	up to 18 months
Primary	Progression Free Survival (PFS)	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.	up to 18 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization until the date of death from any cause.	up to 24 months