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Recruiting NCT07123415

A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Phase I Interventional Advanced Solid Cancer Advanced Solid Tumor (Phase 1)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APX-343A, Pembrolizumab.
Who it may be relevant to
Registry conditions: Advanced Solid Cancer, Advanced Solid Tumor (Phase 1). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug APX-343A
    Oral administration twice daily
  • Drug Pembrolizumab
    intravenous \[IV\]

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 3 centers
  • Seoul National University Bundang Hospital — Seongnam
  • Gangnam Severance Hospital, Yonsei University Health System — Seoul
  • Severance Hospital, Yonsei University Health System — Seoul

Identifiers

NCT: NCT07123415 · APX-343A-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗