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New drug duo shows promise for tough cancers

NCT ID NCT05235542

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two experimental drugs (AK104 and AK117) together, sometimes with chemotherapy, in 128 people with advanced solid tumors. The goal was to see if the combination is safe and can shrink tumors. It focused on patients with stomach, esophageal, or other advanced cancers that had stopped responding to standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

128 people

The number who actually took part.

Started

Mar 2022

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 to 75 years old. 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Have a life expectancy of at least 3 months. 4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor. 5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma. 6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. 7. Has adequate organ function. Exclusion Criteria: 1. Undergone major surgery within 30 days prior to the first dose of study treatment. 2. Active central nervous system (CNS) metastases. 3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. Active Hepatitis B or Hepatitis C. 5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. History of severe bleeding tendency or coagulation disorder.

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Conditions

The condition(s) this trial relates to.

cancer esophageal squamous cell carcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced malignant tumors

Contacts and locations

Locations

  • Shanghai Renji Hospital

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.