> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dose-escalation-and-expansion-study-of-hm16390-alone-or-with-fa4d276d-e729-4407-ad2d-9f8ce1f4e1de > Record changed: 2026-10-13 # Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors NCT06724016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) Participants 292 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) Lead sponsor Hanmi Pharmaceutical Company Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) Start date 2024-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Title and summary **Summary** This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Short title** Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Official title** A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Dates **Completion date** 2031-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **First posted** 2024-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Registry last updated** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Primary completion date** 2031-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Start date** 2024-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Size and sites **Participants** 292 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Planned participants** 292 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Lead sponsor** Hanmi Pharmaceutical Company Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Identifiers **Registry ID** NCT06724016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **ClinicalTrials.gov ID** NCT06724016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Outcomes ### Primary outcomes 1. Incidence and nature of DLTs Timeframe: 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 2. Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. Timeframe: 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 outcomes 1. The maximum serum concentration (Cmax) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 2. The time to reach Cmax (Tmax) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 3. The area under the concentration-time curve from time 0 to the last observable concentration (AUClast) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 4. The AUC extrapolated to infinity (AUCinf) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 5. The AUC during the dosing interval (AUCtau) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 6. The serum concentration at the end of the dosing interval (Ctrough) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 7. The elimination half-life (T1/2) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 8. The apparent volume of distribution (Vd/F) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 9. The apparent clearance (CL/F) Timeframe: Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon HM16390 administration 10. Objective response rate (ORR) Timeframe: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 11. Disease Control Rate (DCR) Timeframe: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 12. Progression-free survival (PFS) Timeframe: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 or until death from any cause, whichever occurs first 13. Duration of response (DOR) Timeframe: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 or death from any cause, whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization. - Age of 18 years or older (or country's legal age of majority if the legal age was >18 years) - Adequate renal function. - Adequate hematologic function. - Adequate liver function. Key Exclusion Criteria: - Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390. - Known active CNS metastases and/or carcinomatous meningitis. - History of severe toxicities associated with a prior immunotherapy. - Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment. - Has ongoing or suspected autoimmune disease. - Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients. - History of chronic liver disease or evidence of hepatic cirrhosis. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Sites - Massachusetts General HospitalBoston, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesNot yet recruiting - Seoul National University Bundang HospitalSeongnam-si, South KoreaRecruiting - Seoul National University HospitalSeoul, South KoreaRecruiting - Severance HospitalSeoul, South KoreaRecruiting - Asan Medical CenterSeoul, South KoreaActive, not recruiting - Samsung Medical CenterSeoul, South KoreaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## References ### Other registry identifiers - KEYNOTE-G39 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06724016) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Hanmi Pharmaceutical Company Limited](https://trialight.com/data/company/hanmi-pharmaceutical-company-limited-87d491ef-e320-4df1-9386-3d2912766c29.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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