Epithelial Tumors, MalignantPhase 1MYE SymphonyNCT05969041
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
A Phase 1 study testing MT-302 (A) in people with Epithelial Tumors, Malignant, run by Myeloid Therapeutics at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Tumors, Malignant
- What is being tested?
- MT-302 (A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesAustralia
- Study dates
- 2 Aug 2023to 31 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Life expectancy of > 12 weeks.
- Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%.
- Electrocardiogram (ECG) showing no clinically significant abnormality at Screening or showing an average QTc interval < 450 msec in males and < 470 msec in females (< 480 msec for participants with bundle branch block). Either Fridericia's or Bazett's formula may be used to correct the QT interval.
- Oxygen saturation of greater than or equal to 90% on room air measured by pulse oximetry.
- Adequate organ function as defined by laboratory values at Screening.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures including undergoing study-related biopsies and attending clinic visits as scheduled.
- Men must abstain from sperm donation during study treatment or for 4 months following last dose of study treatment.
- Men and WOCBP must be willing to practice a highly effective method of contraception.
Who cannot join
- 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.
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- 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.
- Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.
- History of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious active arrhythmias or other clinically significant cardiac disease within 12 months of enrollment.
- Toxicity from previous anti-cancer therapy defined as toxicities (other than alopecia, or laboratory values listed above) not yet resolved to NCI CTCAE v5.0 Grade ≤ 1 or baseline. Participants with chronic Grade 2 toxicities (eg, peripheral neuropathy, laboratory values) may be eligible per the discretion of the Investigator and Medical Monitor.
- Has received:
- Radiotherapy within 2 weeks of first administration of MT-302
- Cytotoxic chemotherapy for treatment of the primary malignancy within 28 days or 5 half-lives, whichever is shorter, of administration of MT-302
- Immune therapy for primary malignancy (eg, monoclonal antibody therapy, checkpoint inhibitors) within 28 days or 5 half-lives, whichever is shorter of first administration of MT-302
- Targeted therapies for primary malignancy within 28 days or 5 half-lives, whichever is shorter, of first administration of MT-302
- Anti-cancer vaccine within 12 weeks of first administration of MT-302
- COVID-19 mRNA vaccine within 6 weeks of first administration of MT-302
- Has received a live vaccine ≤ 6 weeks prior to first administration of MT-302
- Has received packed red blood cells or platelet transfusion within 2 weeks prior to first administration of MT-302
- History of an allergic reaction to any of the excipients
- Enrollment in another interventional clinical trial within 28 days or 5 half-lives of the drug, whichever is shorter, of first administration of MT-302
- Any other condition that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Recruiting
Souther Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, 5042
Ganessan Kichendasse, MD
- Recruiting
St Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, 2010
Rasha Cosman, MD
- Recruiting
Cabrini Health
Malvern, Victoria, 3144
Gary Richardson, MD, 0395089542
Gary Richardson, MD
- Recruiting
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
Timothy Humphries, MD
- Recruiting
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Charlotte Lemech, MD
Charlotte Lemech, MD
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Adnan Nagrial
Adnan Nagrial, MD
About this study
Official title: MYE Symphony: A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
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.
Read the detailed description
The study has 4 Cohorts. Each Cohort has 4 Cycles. For Cohorts 1-3, the dosing regimen will be every 14 days for 3 doses, followed by administration once every 28 days for three doses. For Cohort 4, the dosing regimen will be modified. Participants will receive one dose of MT-302 every week for 3 doses, followed by administration once every 28 days for three additional doses.
A Safety Review Committee (SRC) will provide oversight for this study. The primary responsibility of the SRC is to safeguard study participants by reviewing and assessing the clinical safety data being collected during the conduct of the study.
- Conditions
- Epithelial Tumors, Malignant
- Being tested
- MT-302 (A)
- Keywords
- Urothelial cancer, Cervical cancer, Ovarian epithelial, Triple-negative breast cancer, HR+/HER2- breast cancer, Pancreatic ductal adenocarcinoma, Gastric adenocarcinoma, Esophageal carcinoma, Non-small cell lung cancer, Colorectal cancer, TROP-2 expressing tumors, MT-302, Anti-TROP-2 chimeric antigen receptor, Myeloid cells, Monocytes, Chimeric Antigen Receptor (CAR), mRNA, Lipid nanoparticle (LNP)
- Medical subject headings
- Carcinoma, Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-302 (A)Drug
MT-302 is an investigational drug
| Study group | Role | What they receive |
|---|---|---|
| A (MT-302) | Experimental | Participants will receive MT-302 through intravenous infusion. Receives: Drug: MT-302 (A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Week 20
To establish the maximum tolerated dose (MTD)
based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)
Measured: Up to Week 20
Secondary outcomes (11)
To further characterize the safety of MT-302 through incidence of Adverse Events
Adverse Events will be graded according to the NCI-CTCAE, version 5.0
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Plasma concentrations
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Area under curve (AUC0-last, AUC 0-∞)
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Time of maximum observed plasma concentration (tmax)
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Apparent terminal Half-life (t1/2)
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Plasma Clearance (CL)
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Volume of Distribution (Vd)
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter:Mean residence time (MRT)
Measured: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: terminal rate constant ( λz)
Measured: Up to Week 20
Determine rate of ICANS
For grading of potential immune effector cell-associated neurotoxicity syndrome (ICANS), use of the 10-point immune effector cell-associated encephalopathy (ICE) screening tool
Measured: Up to Week 20
Determine rate of Grade 3-5 CRS
ASCO CRS Grading
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start2 Aug 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Tumors, MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myeloid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Maurer, MD, Study director, Myeloid Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969041
- Sponsor's protocol ID
- MTX-TROP2-302
- Acronym
- MYE Symphony
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYE Symphony: A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT05969041
- Acronym / sponsor ID
- MYE Symphony / MTX-TROP2-302
- Conditions
- Epithelial Tumors, Malignant
- Keywords
- Urothelial cancer, Cervical cancer, Ovarian epithelial, Triple-negative breast cancer, HR+/HER2- breast cancer, Pancreatic ductal adenocarcinoma, Gastric adenocarcinoma, Esophageal carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Myeloid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study has 4 Cohorts. Each Cohort has 4 Cycles. For Cohorts 1-3, the dosing regimen will be every 14 days for 3 doses, followed by administration once every 28 days for three doses. For Cohort 4, the dosing regimen will be modified. Participants will receive one dose of MT-302 every week for 3 doses, followed by administration once every 28 days for three additional doses.
A Safety Review Committee (SRC) will provide oversight for this study. The primary responsibility of the SRC is to safeguard study participants by reviewing and assessing the clinical safety data being collected during the conduct of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A (MT-302) | Experimental | Drug: MT-302 (A)Participants will receive MT-302 through intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-302 (A)MT-302 is an investigational drug | Drug | A (MT-302) |
Primary outcome
To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events
Time frame: Up to Week 20
Adverse Events will be graded according to the NCI-CTCAE, version 5.0
To establish the maximum tolerated dose (MTD)
Time frame: Up to Week 20
based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)
11 secondary outcomes
To further characterize the safety of MT-302 through incidence of Adverse Events
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
Time frame: Up to Week 20
Determine rate of ICANS
Time frame: Up to Week 20
Determine rate of Grade 3-5 CRS
Time frame: Up to Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Maurer, MD study director
Myeloid Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-302 (A) in people with Epithelial Tumors, Malignant, run by Myeloid Therapeutics at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinam Garg (+61 2 9171 3260, Shinam.garg@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events (time frame: Up to Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.