NCT05969041

Brief Summary

MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
28mo left

Started Aug 2023

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Aug 2023Aug 2028

First Submitted

Initial submission to the registry

July 6, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

4.1 years

First QC Date

July 6, 2023

Last Update Submit

January 16, 2024

Conditions

Epithelial Tumors, Malignant

Keywords

Urothelial cancerCervical cancerOvarian epithelialTriple-negative breast cancerHR+/HER2- breast cancerPancreatic ductal adenocarcinomaGastric adenocarcinomaEsophageal carcinomaNon-small cell lung cancerColorectal cancerTROP-2 expressing tumorsMT-302Anti-TROP-2 chimeric antigen receptorMyeloid cellsMonocytesChimeric Antigen Receptor (CAR)mRNALipid nanoparticle (LNP)

Outcome Measures

Primary Outcomes (2)

  • To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events

    Adverse Events will be graded according to the NCI-CTCAE, version 5.0

    Up to Week 20

  • To establish the maximum tolerated dose (MTD)

    based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)

    Up to Week 20

Secondary Outcomes (11)

  • To further characterize the safety of MT-302 through incidence of Adverse Events

    Up to Week 20

  • To assess the pharmacokinetics (PK) of MT-302

    Up to Week 20

  • To assess the pharmacokinetics (PK) of MT-302

    Up to Week 20

  • To assess the pharmacokinetics (PK) of MT-302

    Up to Week 20

  • To assess the pharmacokinetics (PK) of MT-302

    Up to Week 20

  • +6 more secondary outcomes

Study Arms (1)

A (MT-302)

EXPERIMENTAL

Participants will receive MT-302 through intravenous infusion.

Drug: MT-302 (A)

Interventions

MT-302 (A)DRUG

MT-302 is an investigational drug

A (MT-302)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age ≥ 18 inclusive at the time the Informed Consent Form (ICF) is signed.
  • Histologically proven, metastatic or advanced epithelial cancer including the following cancer types:
  • Urothelial
  • Cervical
  • Ovarian epithelial
  • Triple-negative breast
  • HR+/HER2- breast
  • Pancreatic ductal adenocarcinoma
  • Gastric adenocarcinoma
  • Esophageal carcinoma
  • Non-small cell lung
  • Colorectal
  • Progressive disease at baseline, refractory or relapsed to standard of care or who have declined standard therapy.
  • Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.
  • +9 more criteria

You may not qualify if:

  • Known active CNS metastasis and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study intervention.
  • Pregnant or nursing women.
  • Must be \> 28 days beyond major surgery, including hepatectomy or joint replacement.
  • Prior allogeneic bone marrow transplantation or solid organ transplant.
  • Spinal cord compression not definitively treated with surgery and/or radiation.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Any acute illness including fever (\> 100.4° F or \> 38° C) within 7 days prior to Day 1
  • Active systemic bacterial, fungal, or viral infection within 7 days prior to Day 1. Participant cannot have tested positive for COVID-19 within 7 days prior to Day 1.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV).
  • Other primary malignancies, except:
  • Adequately treated basal cell or squamous cell carcinoma
  • In situ carcinoma of the cervix or bladder, treated curatively and without evidence of recurrence for at least 2 years prior to the study, or
  • A primary malignancy which has been completely resected and in complete remission for at least 2 years
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Prior grade \> 3 immune-related AEs such as pneumonitis, colitis, hepatitis, nephritis; prior dermatitis and endocrinopathies are allowed provided corticosteroids are no longer required and endocrine-replacement therapy is stable and discontinued from prior therapy.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St Vincent's Public Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Souther Oncology Clinical Research Unit (SOCRU)

Bedford Park, South Australia, 5042, Australia

RECRUITING

Cabrini Health

Malvern, Victoria, 3144, Australia

RECRUITING

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

CarcinomaUterine Cervical NeoplasmsTriple Negative Breast NeoplasmsEsophageal NeoplasmsCarcinoma, Non-Small-Cell LungColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Matthew Maurer, MD

    Myeloid Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Shinam Garg

CONTACT

+61 2 9171 3260Shinam.garg@novotech-cro.com

Clinical Operations

CONTACT

+1 617 465 1022mt-302clinical@myeloidtx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 1, 2023

Study Start

August 2, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

AU(6)