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BH3120

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 11, 2026

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 Enrollment245
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06234397Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 245Dec 28, 2023Jan 1, 2028Mar 11, 202610 United States, South Korea
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Study Endpoints
Primary Endpoints
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 BH3120 as a single agent and in combination with pembrolizumab administration

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 BH3120 as a single agent and in combination with pembrolizumab administration

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
BH3120EXPERIMENTALArm A: BH3120 Monotherapy
BH3120 + pembrolizumabEXPERIMENTALArm B: BH3120 in combination with pembrolizumab
Interventions
NameTypeDescription
BH3120DRUGBH3120 will be administered as an IV infusion over 90 minutes 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 Sites10

Key Inclusion Criteria: * Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy. * PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1). * Have at least one lesion, ...

Countries:United StatesSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06234397studyFirstPostDate: changed