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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

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment292

FDA Designations

No designations recorded

Clinical trial landscape

HM16390 · 1 trial · 1 indication

Phase 1 1
NCT06724016Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid Tumors
RECRUITING292 Analytics
PHASE1RECRUITING
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid TumorsUnlock trial analytics

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

Frequently asked questions about HM16390

What is HM16390 used for?

HM16390 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development, where it is being studied alone or in combination with pembrolizumab in patients with these types of cancer.

Who makes HM16390?

HM16390 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of HM16390 in patients with advanced or metastatic solid tumors.

What phase is HM16390 in?

HM16390 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is a dose escalation and expansion study evaluating HM16390 alone or with pembrolizumab in advanced or metastatic solid tumors.

What clinical trials is HM16390 in?

HM16390 is being studied in a Phase 1 clinical trial with the identifier NCT06724016. This trial is a dose escalation and expansion study of HM16390 alone or with pembrolizumab in patients with advanced or metastatic solid tumors. The trial is currently recruiting participants in the United States and South Korea.

Is HM16390 being studied in combination with other drugs?

Yes, HM16390 is being studied both alone and in combination with pembrolizumab in a Phase 1 clinical trial for advanced or metastatic solid tumors. The trial is designed to evaluate the safety and efficacy of HM16390 in these settings, with a planned enrollment of 292 participants.