Gastroesophageal Junction AdenocarcinomaPhase 3NCT06206733
ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma
A Phase 3 study testing ASKB589, Oxaliplatin and Capecitabine in people with Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, run by AskGene Pharma, Inc. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
- What is being tested?
- ASKB589, Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 30 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- ASKB589, Oxaliplatin, Capecitabine, Tislelizumab, Placebo
- Keywords
- CLDN 18.2, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, ASKB589
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKB589Drug
ASKB589 will be administered as a minimum 3-hour IV infusion
OxaliplatinDrug
Oxaliplatin will be administered as a minimum 2-hour IV infusion
CapecitabineDrug
Capecitabine will be administered orally twice daily (bid).
TislelizumabDrug
Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
PlaceboDrug
Placebo will be administered as a minimum 3-hour IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment with intravenous infusion of ASKB589 on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria of treatment discontinuation. Receives: Drug: ASKB589; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab |
| Group B | Placebo comparator | Treatment with intravenous infusion of placebo on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria for treatment discontinuation. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until disease progression or withdrawal from the study (generally up to 24 months)
Secondary outcomes (1)
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Until death or withdrawal from the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start25 Jan 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AskGene Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd., Jiangsu Aosaikang Biopharmaceutical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206733
- Sponsor's protocol ID
- ASK-LC-B589-III-1
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06206733
- Acronym / sponsor ID
- ASK-LC-B589-III-1
- Keywords
- CLDN 18.2, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, ASKB589
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- AskGene Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd., Jiangsu Aosaikang Biopharmaceutical Co., Ltd
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: ASKB589, Drug: Oxaliplatin, Drug: Capecitabine, Drug: TislelizumabTreatment with intravenous infusion of ASKB589 on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria of treatment discontinuation. |
| Group B | Placebo comparator | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Tislelizumab, Drug: PlaceboTreatment with intravenous infusion of placebo on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria for treatment discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASKB589ASKB589 will be administered as a minimum 3-hour IV infusion | Drug | Group A |
| OxaliplatinOxaliplatin will be administered as a minimum 2-hour IV infusion | Drug | Group A, Group B |
| CapecitabineCapecitabine will be administered orally twice daily (bid). | Drug | Group A, Group B |
| TislelizumabTislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. | Drug | Group A, Group B |
| PlaceboPlacebo will be administered as a minimum 3-hour IV infusion | Drug | Group B |
Primary outcome
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.
1 secondary outcome
Overall Survival (OS)
Time frame: Until death or withdrawal from the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASKB589, Oxaliplatin and Capecitabine in people with Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, run by AskGene Pharma, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Until disease progression or withdrawal from the study (generally up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.