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Gastric CancerPhase 1/2NCT05632939

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

A Phase 1/2 study testing ASKB589 +CAPOX+Sintilimab/Tislelizumab in people with Gastric Cancer and Gastroesophageal Cancer (GC), run by AskGene Pharma, Inc. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Gastroesophageal Cancer (GC)
What is being tested?
ASKB589 +CAPOX+Sintilimab/Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
21 Feb 2023to 10 Feb 2026
Phase
Phase 1/2
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

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100089

Other trials in China

About this study

Official title: A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.

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.

Read the detailed description

A two-part, dose-escalation and expansion study of ASKB589 was initiated to determine the MTD, PK, PD, and efficacy in combination with chemotherapy and PD-1 inhibitors.

Being tested
ASKB589 +CAPOX+Sintilimab/Tislelizumab
Keywords
CLDN18.2, gastric cancer, gastroesophageal cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASKB589 +CAPOX+Sintilimab/TislelizumabDrug

    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.

Study groups in NCT05632939
Study groupRoleWhat they receive
ASKB589 +CAPOX+Sintilimab/TislelizumabExperimentalOxaliplatin: 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.
Receives: Drug: ASKB589 +CAPOX+Sintilimab/Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 21 days following last dose

  2. 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.

    Measured: up to 21 days following last dose

  3. 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.

    Measured: up to 21 days following last dose

  4. The recommended dose

    The recommended dose will be determined during the dose escalation and dose expansion stage of the study.

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

Secondary outcomes (17)

  1. Pharmacokinetics:maximum Plasma Concentration [Cmax]

    Serum samples will be collected for Cmax analysis.

    Measured: Up to 21 days after injection

  2. Pharmacokinetics:time to maximum observed plasma concentration (Tmax)

    Serum samples will be collected for Tmax analysis.

    Measured: Up to 21 days after injection

  3. Pharmacokinetics:elimination rate constant（Kel）

    Serum samples will be collected for Kel analysis

    Measured: Up to 21 days after injection

  4. Pharmacokinetics:terminal elimination half life (T1/2)

    Serum samples will be collected for T1/2 analysis.

    Measured: Up to 21 days after injection

  5. Pharmacokinetics:apparent volume of distribution (Vz/F)

    Serum samples will be collected for Vz/F analysis.

    Measured: Up to 21 days after injection

  6. Pharmacokinetics:Area Under Curve (AUC)

    Serum samples will be collected for AUC analysis.

    Measured: Up to 21 days after injection

  7. Pharmacokinetics: Mean ResidenceTime（MRT）

    Serum samples will be collected for MRT analysis.

    Measured: Up to 21 days after injection

  8. Pharmacokinetics: plasma clearance rate (CL)

    Serum samples will be collected for CL analysis.

    Measured: Up to 21 days after injection

  9. Pharmacokinetics: steady-state peak concentration (Css_max)

    Serum samples will be collected for Css_max analysis.

    Measured: Up to 21 days after injection

  10. Pharmacokinetics: time to steady-state peak concentration (Tss_max)

    Serum samples will be collected for Tss_max analysis.

    Measured: Up to 21 days after injection

  11. Pharmacokinetics: minimum value of steady plasma drug concentration（Css_min）

    Serum samples will be collected for Css max analysis.

    Measured: Up to 21 days after injection

  12. Evaluation of immunogenicity

    Incidence of anti-drug antibodies (ADA)

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

  13. Objective response rate（ORR）

    Evaluation of objective response rate assessed by RECIST 1.1

    Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years

  14. disease control rate（DCR)

    Evaluation of Disease control rate assessed by RECIST 1.1

    Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years

  15. Duration of Response（DOR）

    Duration of response assessed by RECIST 1.1

    Measured: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years

  16. Progression free survival（PFS）

    Progression of tumor will be measured by RECIST v1.1

    Measured: from date of treatment start until the date of disease progression or until death due to any causes, up to 2 years

  17. Overall survival（OS）

    defined as the time from the date of treatment start until date of death due to any cause.

    Measured: from the date of treatment start until the documented date of death from any cause，up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start21 Feb 2023
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion10 Feb 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632939
Sponsor's protocol ID
ASK-LC-B589- Ib/II
Status last verified
Sep 2025
First submitted
21 Nov 2022
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASKB589 +CAPOX+Sintilimab/Tislelizumab in people with Gastric Cancer and Gastroesophageal Cancer (GC), 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 8 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 10 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Number of participants with adverse events as assessed by CTCAE v5.0 (time frame: up to 21 days following last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05632939.

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 10 Sep 2025.

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