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

NCT06724016 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DRUG

HM16390

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

DRUG

pembrolizumab

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2031-07-31
Completion
2031-07-31
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724016 on ClinicalTrials.gov