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APX-343A

Phase 1

Advanced Solid Cancer | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: Oct 9, 2026

APX-343A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

APX-343A clinical trials

APX-343A · 1 trial · 2 indications

Phase 1 1
NCT07123415A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid TumorsAdvanced Solid Cancer
RECRUITING110 Analytics
PHASE1RECRUITING
A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Advanced Solid Cancer
NCT07123415110
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Study Endpoints

Primary Endpoints

To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab
From enrollment to 90 days after End Of Treatment

Number and severity of TEAEs according to NCI-CTCAE v5.0

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A : APX-343AEXPERIMENTALPart A is a dose-escalation study of APX-343A monotherapy in subjects with advanced solid tumors.
Part BEXPERIMENTALPart B is a dose-escalation study of APX-343A in combination with pembrolizumab, targeting subjects with advanced solid tumors.

Interventions

NameTypeDescription
APX-343ADRUGOral administration twice daily
PembrolizumabDRUGintravenous \[IV\]
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Eligibility Criteria

Age Range19 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Male or female subjects aged ≥19 years, inclusive, at the time of informed consent. 2. Willing and able to give informed consent and to comply with the requirements of the study. 3. Histologically or cytologically confirmed advanced solid tumor. 4. Life expectancy of at least...

Countries:South Korea
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