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New drug combo targets Hard-to-Treat cancers

NCT ID NCT07123415

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests a new drug, APX-343A, alone or with another cancer drug (pembrolizumab) in people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see if the drug shrinks tumors. About 110 adults with advanced cancer will take part.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

An individual researcher

The lead sponsor is a named person rather than an organisation.

Who can take part

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

Ages

19 years and older

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. Male or female subjects aged ≥19 years, inclusive, at the time of informed consent. 2. Willing and able to give informed consent and to comply with the requirements of the study. 3. Histologically or cytologically confirmed advanced solid tumor. 4. Life expectancy of at least 3 months in the judgment of the investigator. 5. ECOG performance status of 0 to 1 during the screening period. 6. Measurable disease per RECIST v1.1 as assessed by the site investigator/radiology. 7. Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided. 8. Subjects who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline. 9. Adequate organ function as defined in the following table. 10. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to the first dose of study drug. 11. Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening. 12. Male subjects must agree to use an adequate method of contraception. 13. Female subjects of childbearing potential must agree to use highly effective contraceptive methods, and to abstain from breastfeeding. Exclusion Criteria: 1. Received any prior immunotherapy. 2. Received prior systemic anticancer therapy including investigational agents. 3. Received prior radiotherapy. 4. Received a live or live-attenuated vaccine . 5. Has received an investigational agent. 6. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. 7. Known additional malignancy. 8. Known active CNS metastases and/or carcinomatous meningitis. 9. Active autoimmune disease. 10. History of (noninfectious) pneumonitis/interstitial lung disease. 11. Active, uncontrolled infection requiring systemic therapy. 12. Unable to swallow study drug or disease that interfere with proper absorption of study drug. 13. Significant cardiovascular disease. 14. Cerebrovascular accident. 15. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's ability to cooperate with the requirements of the study. 16. History of severe hypersensitivity to pembrolizumab and/or any of its excipients. 17. History of hypersensitivity to APX-343A and/or any of its excipients. 18. History of allogeneic tissue/solid organ transplant. 19. History of HIV infection or HIV positive at screening. 20. Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, South Korea

More trials for these conditions

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