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

NCT07334119 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • HER2-Expressing Solid Tumors

Interventions

DRUG

MT-304

Safety, tolerability, and pharmacokinetics will be evaluated.

DRUG

MT-304 + Nivolumab

Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.

Sponsors & Collaborators

  • CREATE Medicines

    collaborator UNKNOWN

  • Myeloid Therapeutics

    lead INDUSTRY

Principal Investigators

  • Matthew Maurer, MD · Myeloid Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2027-01-31
Completion
2028-03-30

Countries

  • Australia

Study Locations

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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 NCT07334119 on ClinicalTrials.gov