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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

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment245

FDA Designations

No designations recorded

Clinical trial landscape

BH3120 · 1 trial · 1 indication

Phase 1 1
NCT06234397Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid Tumors
RECRUITING245 Analytics
PHASE1RECRUITING
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced or Metastatic Solid Tumors")

Frequently asked questions about BH3120

What is BH3120 used for?

BH3120 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently being studied in a Phase 1 clinical trial that includes patients with these types of cancer. The drug is administered either alone or in combination with pembrolizumab, another cancer therapy.

Who makes BH3120?

BH3120 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of BH3120 in patients with advanced or metastatic solid tumors.

What phase is BH3120 in?

BH3120 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is a dose escalation and expansion study that is actively recruiting participants with advanced or metastatic solid tumors.

What clinical trials is BH3120 in?

BH3120 is being studied in a single Phase 1 clinical trial registered as NCT06234397. This trial is titled 'Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors' and is currently recruiting participants in the United States and South Korea.

Is BH3120 being tested in combination with other drugs?

Yes, BH3120 is being evaluated both as a monotherapy and in combination with pembrolizumab in a Phase 1 clinical trial. The trial is designed to assess the safety and tolerability of BH3120 when given alone or with pembrolizumab in patients with advanced or metastatic solid tumors.

What is the enrollment size for the BH3120 clinical trial?

The Phase 1 clinical trial for BH3120, identified as NCT06234397, has a planned enrollment of 245 participants. The study is currently recruiting patients aged 18 years and older with advanced or metastatic solid tumors, and it is being conducted at sites in the United States and South Korea.