Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors

Sponsor
Myeloid Therapeutics
Study ID
NCT07334119
Phase
PHASE1
Status
Recruiting
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Conditions

  • HER2-Expressing Solid Tumors

Eligibility Criteria

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

Interventions

  • MT-304 — DRUG
    Safety, tolerability, and pharmacokinetics will be evaluated.
  • MT-304 + Nivolumab — DRUG
    Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.

Study Details

This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are: * What is the safety profile of MT-304 when administered alone or with nivolumab? * What is the recommended Phase 2 dose (RP2D) of MT-304? Participants will: * Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days). * Attend regular clinic visits for assessments and monitoring. * Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.

Key Dates

Start date
Nov 25, 2025
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MT-304 Monotherapy
    Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels.
  • Experimental: MT-304 + Nivolumab Combination Therapy
    Participants receive MT-304 administered intravenously once every 14 days (Q14D) in combination with nivolumab as "per local label" administered once every 28 days (Q28D).

Primary Outcome Measure

Type, incidence and severity of Adverse Events [ Time Frame: Up to 90 days from the last dose of Investigational Medicinal Product (IMP) ]

Central Contacts