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

NCT07123415 | Recruiting Phase 1

• 1 other identifier: APX-343A-101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Solid Cancer; Advanced Solid Tumor (Phase 1)

Keywords

Advanced Solid Cancer; Advanced Solid Tumor (Phase 1); APX-343A; ICI; CAF; NOX

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to 90 days after End Of Treatment

Secondary Outcomes (6)

• Cmax of APX-343A

  From enrollment to 3 weeks

• AUC of APX-343A

  From enrollment to 3 weeks

• Tmax of APX-343A

  From enrollment to 3 weeks

• t1/2 of APX-343A

  From enrollment to 3 weeks

• CL of APX-343A

  From enrollment to 3 weeks

Study Arms (2)

Part A : APX-343A

EXPERIMENTAL

Part A is a dose-escalation study of APX-343A monotherapy in subjects with advanced solid tumors.

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.

Drug: APX-343A; Drug: Pembrolizumab

Interventions

APX-343A DRUG

Oral administration twice daily

Part A : APX-343A; Part B

Pembrolizumab DRUG

intravenous \[IV\]

Part B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aptabio Therapeutics, Inc.: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Clinical Center, Clinical Center

CONTACT

+82-31-365-3693; cd@aptabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 14, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

KR (3)