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HM16390

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Dec 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment292
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06724016Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 292Dec 11, 2024Jul 1, 2031Dec 17, 20257 United States, South Korea
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Study Endpoints
Primary Endpoints
Incidence and nature of DLTs
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part

To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab

Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Throughout the study until end of safety follow-up period (90 days after the last treatment)

To evaluate safety and tolerability of HM16390 as a single agent, and in combination with pembrolizumab

Secondary Endpoints
The maximum serum concentration (Cmax)
Throughout the study until treatment discontinuation (up to 2-3 years)
The time to reach Cmax (Tmax)
Throughout the study until treatment discontinuation (up to 2-3 years)
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Throughout the study until treatment discontinuation (up to 2-3 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HM16390EXPERIMENTALHM16390 Monotherapy
HM16390 + pembrolizumabEXPERIMENTALHM16390 in combination with pembrolizumab
Interventions
NameTypeDescription
HM16390DRUGHM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle
pembrolizumabDRUGFixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: * Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit. * Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patient...

Countries:United StatesSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06724016studyFirstPostDate: changed