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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT06724016
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 11, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
292 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HM16390
    HM16390 Monotherapy
  • Experimental: HM16390 + pembrolizumab
    HM16390 in combination with pembrolizumab

Primary Outcome Measure

Incidence and nature of DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MAKarmanos Cancer Institute· Detroit, MI

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