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Gastric and Gastroesophageal Junction AdenocarcinomaPhase 3NCT06341335

A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 3 study testing cadonilimab, pulocimab and paclitaxel in people with Gastric and Gastroesophageal Junction Adenocarcinoma, run by Akeso at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
cadonilimab, pulocimab and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
506 participants
Where
1 siteChina
Study dates
19 Jun 2024to Jul 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age ≥ 18 years and ≤ 75 years
  • Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
  • Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
  • At least one measurable disease based on RECIST v1.1
  • ECOG status of 0 or 1
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  • Estimated survival ≥ 3 months
  • Adequate organ function per protocol-defined criteria
  • Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment

Who cannot join

  • Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
  • HER2-positive
  • Known other invasive malignancies within 3 years
  • Subjects who are currently participating in other interventional study
  • Received prior systemic anti-tumour therapy within 4 weeks before randomization
  • Previous systemic treatment with taxane within 6 months before randomization
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  • Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
  • In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
  • History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
  • History of severe infection within 4 weeks prior to randomization
  • Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
  • History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
  • Major surgical procedure or serious trauma within 28 days prior to randomization
  • History of interstitial lung disease or noninfectious pneumonitis
  • Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
  • Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
  • History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
  • Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
  • Use of live vaccines within 30 days prior to randomization
  • Pregnant or lactating women.
  • Any condition considered by the investigator to be inappropriate for enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ting Liu contact

+86(0760)8987 3999

clinicaltrials@akesobio.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital & Institute

    Beijing

    Lin Shen, MD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Phase 3 Study Of Cadonilimab (AK104) Plus Pulocimab (AK109) And Paclitaxel Versus Paclitaxel In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma Who Failed First-line Immunochemotherapy

This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.

Being tested
cadonilimab, pulocimab, paclitaxel, placebo

What participants receive

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

  • cadonilimabDrug

    Also called AK104

    iv, q3w

  • pulocimabDrug

    Also called AK109

    iv, q3w

  • paclitaxelDrug

    iv, q3w

  • placeboDrug

    iv, q3w

Study groups in NCT06341335
Study groupRoleWhat they receive
Cadonilimab in combination with pulocimab and paclitaxelExperimentalCadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks
Receives: Drug: cadonilimab; Drug: pulocimab; Drug: paclitaxel
Placebo in combination with paclitaxelActive comparatorPlacebo in combination with Paclitaxel, iv, every 3 weeks
Receives: Drug: paclitaxel; Drug: placebo

What is being measured

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

  1. Progression-free survival (PFS) assessed by blinded independent central review (BICR)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).

    Measured: Up to 2 years

  2. Overall survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Progression-free survival (PFS) assessed by investigator

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).

    Measured: Up to 2 years

  2. Objective Response Rate (ORR)

    ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria

    Measured: Up to 2 years

  3. Duration of Response (DoR)

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  4. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).

    Measured: 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 posted2 Apr 2024
  2. Study start19 Jun 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionJul 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
506 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341335
Sponsor's protocol ID
AK109-301
Status last verified
Jun 2024
First submitted
26 Mar 2024
Last updated
24 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cadonilimab, pulocimab and paclitaxel in people with Gastric 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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 24 Jun 2024. 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 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?

Contact Ting Liu (+86(0760)8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by blinded independent central review (BICR) (time frame: Up to 2 years). The study lists 2 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 NCT06341335.

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 24 Jun 2024.

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