Advanced Solid CancerPhase 1NCT07123415
A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
A Phase 1 study testing APX-343A and Pembrolizumab in people with Advanced Solid Cancer and Advanced Solid Tumor (Phase 1), run by Aptabio Therapeutics, Inc. at 3 sites in South Korea.
Trial summary
This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Cancer, Advanced Solid Tumor (Phase 1)
- What is being tested?
- APX-343A and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 24 Oct 2025to Dec 2028
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.
- Willing and able to give informed consent and to comply with the requirements of the study.
- Histologically or cytologically confirmed advanced solid tumor.
- Life expectancy of at least 3 months in the judgment of the investigator.
- ECOG performance status of 0 to 1 during the screening period.
- Measurable disease per RECIST v1.1 as assessed by the site investigator/radiology.
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- Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- Subjects who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline.
- Adequate organ function as defined in the following table.
- 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.
- Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening.
- Male subjects must agree to use an adequate method of contraception.
- Female subjects of childbearing potential must agree to use highly effective contraceptive methods, and to abstain from breastfeeding.
Who cannot join
- Received any prior immunotherapy.
- Received prior systemic anticancer therapy including investigational agents.
- Received prior radiotherapy.
- Received a live or live-attenuated vaccine .
- Has received an investigational agent.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
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- Known additional malignancy.
- Known active CNS metastases and/or carcinomatous meningitis.
- Active autoimmune disease.
- History of (noninfectious) pneumonitis/interstitial lung disease.
- Active, uncontrolled infection requiring systemic therapy.
- Unable to swallow study drug or disease that interfere with proper absorption of study drug.
- Significant cardiovascular disease.
- Cerebrovascular accident.
- 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.
- History of severe hypersensitivity to pembrolizumab and/or any of its excipients.
- History of hypersensitivity to APX-343A and/or any of its excipients.
- History of allogeneic tissue/solid organ transplant.
- History of HIV infection or HIV positive at screening.
- Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Keun-Wook Lee
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul
Hei-Cheul Jeung
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Sun-Young Rha
About this study
Official title: A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors
This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.
- Being tested
- APX-343A, Pembrolizumab
- Keywords
- Advanced Solid Cancer, Advanced Solid Tumor (Phase 1), APX-343A, ICI, CAF, NOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APX-343ADrug
Oral administration twice daily
PembrolizumabDrug
intravenous [IV]
| Study group | Role | What they receive |
|---|---|---|
| Part A : APX-343A | Experimental | Part A is a dose-escalation study of APX-343A monotherapy in subjects with advanced solid tumors. Receives: Drug: APX-343A |
| Part B | Experimental | Part B is a dose-escalation study of APX-343A in combination with pembrolizumab, targeting subjects with advanced solid tumors. Receives: Drug: APX-343A; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab
Number and severity of TEAEs according to NCI-CTCAE v5.0
Measured: From enrollment to 90 days after End Of Treatment
Secondary outcomes (6)
Cmax of APX-343A
To characterize the PK of APX 343A monotherapy
Measured: From enrollment to 3 weeks
AUC of APX-343A
To characterize the PK of APX-343A monotherapy
Measured: From enrollment to 3 weeks
Tmax of APX-343A
To characterize the PK of APX-343A monotherapy
Measured: From enrollment to 3 weeks
t1/2 of APX-343A
To characterize the PK of APX-343A monotherapy
Measured: From enrollment to 3 weeks
CL of APX-343A
To characterize the PK of APX-343A monotherapy
Measured: From enrollment to 3 weeks
Response rate according to RECIST v1.1 and iRECIST
To evaluate preliminary efficacy of APX-343A monotherapy and in combination with pembrolizumab
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start24 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123415
- Sponsor's protocol ID
- APX-343A-101
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07123415
- Acronym / sponsor ID
- APX-343A-101
- Keywords
- Advanced Solid Cancer, Advanced Solid Tumor (Phase 1), APX-343A, ICI, CAF, NOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A : APX-343A | Experimental | Drug: APX-343APart A is a dose-escalation study of APX-343A monotherapy in subjects with advanced solid tumors. |
| Part B | Experimental | Drug: APX-343A, Drug: PembrolizumabPart B is a dose-escalation study of APX-343A in combination with pembrolizumab, targeting subjects with advanced solid tumors. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.
- Willing and able to give informed consent and to comply with the requirements of the study.
- Histologically or cytologically confirmed advanced solid tumor.
- Life expectancy of at least 3 months in the judgment of the investigator.
- ECOG performance status of 0 to 1 during the screening period.
Key exclusion criteria (20 listed)
- Received any prior immunotherapy.
- Received prior systemic anticancer therapy including investigational agents.
- Received prior radiotherapy.
- Received a live or live-attenuated vaccine .
- Has received an investigational agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APX-343AOral administration twice daily | Drug | Part A : APX-343A, Part B |
| Pembrolizumabintravenous [IV] | Drug | Part B |
Primary outcome
To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab
Time frame: From enrollment to 90 days after End Of Treatment
Number and severity of TEAEs according to NCI-CTCAE v5.0
6 secondary outcomes
Cmax of APX-343A
Time frame: From enrollment to 3 weeks
AUC of APX-343A
Time frame: From enrollment to 3 weeks
Tmax of APX-343A
Time frame: From enrollment to 3 weeks
t1/2 of APX-343A
Time frame: From enrollment to 3 weeks
CL of APX-343A
Time frame: From enrollment to 3 weeks
Response rate according to RECIST v1.1 and iRECIST
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APX-343A and Pembrolizumab in people with Advanced Solid Cancer and Advanced Solid Tumor (Phase 1), run by Aptabio Therapeutics, Inc. at 3 sites in South Korea.
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 13 inclusion and 20 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 9 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 3 sites in South Korea. 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 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.
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 Clinical Center, Clinical Center (+82-31-365-3693, cd@aptabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab (time frame: From enrollment to 90 days after End Of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.