Actively Recruiting
A Phase 1 Trial of APX-343A Alone or With Pembrolizumab to Assess Safety, Tolerability, and Preliminary Effects in Advanced Solid Tumors
Led by Aptabio Therapeutics, Inc. · Updated on 2025-11-19
110
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of APX-343A alone and combined with pembrolizumab in adults with advanced solid tumors. This study aims to understand how these treatments work in patients with serious cancer conditions and to find appropriate dosing levels. The study is divided into two parts. Part A involves gradually increasing doses of APX-343A given orally twice daily as a monotherapy, while Part B tests increasing doses of APX-343A combined with pembrolizumab, which is administered intravenously. Both parts focus on patients with advanced solid tumors, with the goal of determining safe and tolerable doses for future research. Participants will be monitored from enrollment through treatment and up to 90 days after treatment ends to assess safety and tolerability. Researchers will also measure how the body processes APX-343A over three weeks and track tumor response for about a year using imaging criteria. The study requires patients to provide tumor tissue samples and undergo regular evaluations, including physical exams and lab tests, to ensure safety and gather detailed information on treatment effects.
CONDITIONS
Brief 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 aged 19 years or older at consent
- Willing and able to give informed consent and follow study requirements
- Confirmed advanced solid tumor by tissue analysis
- Life expectancy of at least 3 months as judged by investigator
- ECOG performance status of 0 or 1 during screening
- Measurable disease by RECIST v1.1 criteria
- Provided archival tumor tissue or new biopsy from non-irradiated lesion
- Recovered to Grade 1 or baseline from previous anticancer therapy side effects
- Adequate organ function as specified by study
- Hepatitis B positive subjects must have completed antiviral therapy and have undetectable viral load
- Subjects with past hepatitis C infection must have undetectable viral load at screening
- Male subjects agree to use contraception
- Females of childbearing potential agree to use highly effective contraception and not breastfeed
You will not qualify if you...
- Prior immunotherapy treatment
- Prior systemic anticancer therapy including investigational drugs
- Prior radiotherapy
- Receipt of live or live-attenuated vaccine
- Use of investigational agents
- Diagnosis of immunodeficiency or chronic systemic steroid use
- Additional known malignancy
- Active CNS metastases or carcinomatous meningitis
- Active autoimmune disease
- History of pneumonitis or interstitial lung disease
- Active, uncontrolled infection needing systemic treatment
- Unable to swallow study drug or conditions affecting absorption
- Significant cardiovascular disease
- Cerebrovascular accident history
- Conditions or therapies that could interfere with study results or cooperation
- Severe hypersensitivity to pembrolizumab or APX-343A
- History of organ or tissue transplant
- HIV infection or positive at screening
- Not recovered from major surgery or ongoing surgical complications after surgery completion period required by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to end of treatment (varies per participant)
Participants receive APX-343A orally twice daily alone or in combination with intravenous pembrolizumab as part of a dose-escalation study for advanced solid tumors.
Regular visits during treatment as determined by study protocol
Duration - Up to 90 days after end of treatment
Participants are monitored for safety and treatment effects for up to 90 days after end of treatment.
Visits for safety assessments during follow-up period
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
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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