New drug combo targets Hard-to-Treat cancers
NCT ID NCT07123415
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGSeoul, South Korea
-
Seoul National University Bundang Hospital
RECRUITINGSeongnam, South Korea
-
Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug that targets two cancer drivers tested in first human study
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- New antibody drug conjugate tested against advanced cancers