AzTrials
AzTrials

Gastric AdenocarcinomaPhase 1/2NCT06586294

A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma

A Phase 1/2 study testing Drug: AK129 Drug：oxaliplatin Drug：capecitabine and Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Drug: AK129 Drug：oxaliplatin Drug：capecitabine and Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
30 Sep 2024to 20 Apr 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must sign the written informed consent form(ICF) voluntarily.
  • Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
  • Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).
  • Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
  • According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.

Who cannot join

  • Subjects with known HER2 positive gastric or gastroesophageal junction adenocarcinoma.
  • Histopathological examination confirmed other pathological types.
  • Had received palliative local therapy for non-target lesions within 2 weeks before the first administration.
  • Past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune cell therapy and any treatment targeting the immune mechanism of tumor action.
  • History of gastrointestinal perforation and fistula within 6 months before the first dose.
  • Active or previously documented inflammatory bowel disease,inability to swallow, malabsorption syndrome.
Show all 10Show fewer
  • Active malignancy within the last 3 years.
  • Active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia meningeal disease are known to exist.
  • The presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage.
  • There was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Cancer Hospital

    Hanzhou, Zhejiang, 310005

Other trials in China

About this study

Official title: A Phase Ib/II Open Label,Dose Escalation and Dose Extension Study Evaluating the Safety, Tolerability, and Initial Antitumor Efficacy of Anti-PD-1 and Lymphocyte Activation Gene 3(LAG-3) Bispecific Antibody AK129 Combined With Chemotherapy With or Without Cadonilimab in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Negative Unresectable Locally Advanced or Metastatic G/GEJ Adenocarcinoma

Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma

Being tested
Drug: AK129 Drug：oxaliplatin Drug：capecitabine, Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabine

What participants receive

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

  • Drug: AK129 Drug：oxaliplatin Drug：capecitabineDrug

    The study drug will be administered at the specified dose and frequency.

  • Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabineDrug

    The study drug will be administered at the specified dose and frequency.

Study groups in NCT06586294
Study groupRoleWhat they receive
The dose escalation and expansion stage of AK129 combined with chemotherapy;ExperimentalPart 1: The dose escalation stage# 3 dose groups of AK129 were set up, combination with chemotherapy of XELOX,followed by AK129 and capecitabine maintenance; Part 2#The dose expansion stage# Two to three dosing regimens were set for expansion of AK129 in combination with XELOX.
Receives: Drug: Drug: AK129 Drug：oxaliplatin Drug：capecitabine
The dose escalation and expansion stage of AK129 combined with chemotherapy with cadonilimabExperimentalPart 1:The dose escalation stage# 3 dose groups of AK129 were set up, combination with cadonilimab and chemotherapy of XELOX,followed by AK129 and cadonilimab maintenance; Part 2:The dose expansion stage# Two to three dosing regimens were set for expansion of AK129 in combination with cadonilimab and chemotherapy of XELOX.
Receives: Drug: Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabine

What is being measured

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

  1. Incidence and severity of adverse events(AE)

    Incidence and severity of AEs is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab

    Measured: Up to approximately 2 years

  2. Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR)

    Incidence of SAE and SUSAR is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab

    Measured: Up to approximately 2 years

  3. Incidence of dose-limiting toxicity(DLT)

    The purpose of DLT is to find the Phase II recommended dose(RP2D) or Maximum Tolerated Dose(MTD)

    Measured: Up to approximately 2 years

  4. Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension

    Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab

    Measured: Up to approximately 2 years

  5. Objective Solution Rate (ORR) based on RECIST v1.1

    The purpose of ORR is aim to evaluate the antitumor effect,and ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Disease control rate(DCR)

    Disease control rate(DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR or PR or stable disease(SD) per RECIST v1.1.

    Measured: Up to approximately 2 years

  2. duration of response(DoR)

    Duration of response(DoR) is defined as the period from the first documentation of confirmed response(CR or PR) to the first documentation of progressive disease(PD) as per RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. time to response(TTR)

    Time to response(TTR) is defined as the time from the first dose of investigational products until the first confirmation of CR or PR.

    Measured: Up to approximately 2 years

  4. progression-free survival(PFS)

    Progression-free survival(PFS) is defined as the time from the first dose of investigational products until documentation of progressive disease(PD) as per RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  5. overall survival(OS)

    Overall survival(OS) is defined as the time from the first dose of investigational products until death due to any cause.

    Measured: Up to approximately 2 years

  6. Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument

    Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument to evaluate the Pharmacokinetics(PK).

    Measured: Up to approximately 2 years

  7. Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab

    Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: Up to approximately 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 posted19 Sep 2024
  2. Study start30 Sep 2024
  3. Primary completion20 Apr 2026
  4. Study completion20 Apr 2026

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
Non-randomised
Intervention model
Parallel groups
Model description
Phase 1b/II, open-label, 2-part, multicenter, non-randomized, multiple-dose study
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06586294
Sponsor's protocol ID
AK129-103
Status last verified
Oct 2026
First submitted
4 Sep 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Drug: AK129 Drug：oxaliplatin Drug：capecitabine and Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Akeso 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 10 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: finished, as of the sponsor's last update on 16 Oct 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence and severity of adverse events(AE) (time frame: Up to approximately 2 years). The study lists 5 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 NCT06586294.

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 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in