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

NCT07123415 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-11-19

No results posted yet for this study

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)

Interventions

DRUG

APX-343A

Oral administration twice daily

DRUG

Pembrolizumab

intravenous \[IV\]

Sponsors & Collaborators

  • Aptabio Therapeutics, Inc.

    lead INDIV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07123415 on ClinicalTrials.gov