Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors

NCT06724016 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: HM-LIL2-101KEYNOTE-G39MK-3475-G39
• Study Type: interventional
• Target: 292
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence and nature of DLTs

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

  At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part

• Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.

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

  Throughout the study until end of safety follow-up period (90 days after the last treatment)

Secondary Outcomes (13)

• 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)

• The AUC extrapolated to infinity (AUCinf)

  Throughout the study until treatment discontinuation (up to 2-3 years)

• The AUC during the dosing interval (AUCtau)

  Throughout the study until treatment discontinuation (up to 2-3 years)

Study Arms (2)

HM16390

EXPERIMENTAL

HM16390 Monotherapy

Drug: HM16390

HM16390 + pembrolizumab

EXPERIMENTAL

HM16390 in combination with pembrolizumab

Drug: HM16390; Drug: pembrolizumab

Interventions

pembrolizumab DRUG

Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Also known as: KEYTRUDA®

HM16390 + pembrolizumab

HM16390 DRUG

HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle

HM16390; HM16390 + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: collaborator
• Hanmi Pharmaceutical Company Limited: lead

Study Sites (7)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Young Su (Bobby) Noh

CONTACT

82-2-410-9277; 63forever@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1. Dose-Escalation Part: Divided into 2 arms (Arm A: HM16390 monotherapy, Arm B: HM16390 in combination with pembrolizumab) 2. Dose-Ranging Part: Subjects will be randomized 1:1 into at least two dose levels to enable better selection of the doses for further evaluation, and may apply to cohorts of both monotherapy and combination therapy 3. Dose-Expansion Part: Based on the available data from Dose-Escalation and Dose-Ranging parts, the most feasible dose will be selected as the RDE and will be administered to subjects in indication-specific expansion cohorts

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 9, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); KR (5)