Actively Recruiting
A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Led by Aptabio Therapeutics, Inc. · Updated on 2025-11-19
110
Participants Needed
3
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 6019 years or older at the time of consent
- Willing and able to give informed consent and follow study requirements
- Histologically or cytologically confirmed advanced solid tumor
- Life expectancy of at least 3 months as judged by the investigator
- ECOG performance status of 0 to 1 during screening
- Measurable disease per RECIST v1.1 criteria
- Provided archival tumor tissue or new biopsy from a non-irradiated tumor lesion
- Recovered to Grade 1 or baseline from adverse events due to prior anticancer therapies
- Adequate organ function according to study-defined criteria
- Hepatitis B surface antigen positive subjects must have received antiviral therapy for at least 4 weeks and have undetectable viral load before first dose
- Subjects with history of HCV infection must have undetectable viral load at screening
- Male subjects agree to use adequate contraception
- Female subjects of childbearing potential agree to use highly effective contraception and abstain from breastfeeding
You will not qualify if you...
- Received any prior immunotherapy
- Received prior systemic anticancer therapy including investigational agents
- Received prior radiotherapy
- Received a live or live-attenuated vaccine
- Received an investigational agent
- Diagnosis of immunodeficiency or on chronic systemic steroid therapy
- Known additional malignancy
- Known active CNS metastases or carcinomatous meningitis
- Active autoimmune disease
- History of noninfectious pneumonitis or interstitial lung disease
- Active, uncontrolled infection requiring systemic treatment
- Unable to swallow study drug or with disease interfering with drug absorption
- Significant cardiovascular disease
- Cerebrovascular accident
- Any condition or therapy that might confound study results or interfere with cooperation
- History of severe hypersensitivity to pembrolizumab or its components
- History of hypersensitivity to APX-343A or its components
- History of allogeneic tissue or solid organ transplant
- History of HIV infection or HIV positive at screening
- Not fully recovered from major surgery or with ongoing surgical complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
2
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
3
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
C
Clinical Center, Clinical Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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