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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors

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

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors (NCT05969041) is a Phase 1 interventional studying Epithelial Tumors, Malignant, sponsored by Myeloid Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Epithelial Tumors, Malignant, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults age ≥ 18 inclusive at the time the willing to sign a consent form Form (ICF) is signed. 2. Histologically proven, metastatic or advanced epithelial cancer including the following cancer types: 1. Urothelial 2. Cervical 3. Ovarian epithelial 4. Triple-negative breast 5. HR+/HER2- breast 6. Pancreatic ductal adenocarcinoma 7. Gastric adenocarcinoma 8. Esophageal carcinoma 9. Non-small cell lung 10. Colorectal 3. Progressive disease at baseline, refractory or relapsed to standard of care or who have declined standard therapy. 4. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1. 6. Life expectancy of \> 12 weeks. 7. Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%. 8. 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. 9. Oxygen saturation of greater than or equal to 90% on room air measured by pulse oximetry. 10. your organs (liver, kidneys, etc.) are working well enough based on blood tests as defined by laboratory values at Screening. 11. Willing and able to provide written willing to sign a consent form. 12. Willing to perform and comply with all study procedures including undergoing study-related biopsies and attending clinic visits as scheduled. 13. Men must abstain from sperm donation during study treatment or for 4 months following last dose of study treatment. 14. Men and WOCBP must be willing to practice a highly effective method of contraception. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adults age ≥ 18 inclusive at the time the Informed Consent Form (ICF) is signed. 2. Histologically proven, metastatic or advanced epithelial cancer including the following cancer types: 1. Urothelial 2. Cervical 3. Ovarian epithelial 4. Triple-negative breast 5. HR+/HER2- breast 6. Pancreatic ductal adenocarcinoma 7. Gastric adenocarcinoma 8. Esophageal carcinoma 9. Non-small cell lung 10. Colorectal 3. Progressive disease at baseline, refractory or relapsed to standard of care or who have declined standard therapy. 4. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1. 6. Life expectancy of \> 12 weeks. 7. Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%. 8. 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. 9. Oxygen saturation of greater than or equal to 90% on room air measured by pulse oximetry. 10. Adequate organ function as defined by laboratory values at Screening. 11. Willing and able to provide written informed consent. 12. Willing to perform and comply with all study procedures including undergoing study-related biopsies and attending clinic visits as scheduled. 13. Men must abstain from sperm donation during study treatment or for 4 months following last dose of study treatment. 14. Men and WOCBP must be willing to practice a highly effective method of contraception. Exclusion Criteria: 1. 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. 2. Pregnant or nursing women. 3. Must be \> 28 days beyond major surgery, including hepatectomy or joint replacement. 4. Prior allogeneic bone marrow transplantation or solid organ transplant. 5. Spinal cord compression not definitively treated with surgery and/or radiation. 6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 7. Any acute illness including fever (\> 100.4° F or \> 38° C) within 7 days prior to Day 1 8. 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. 9. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV). 10. Other primary malignancies, except: 1. Adequately treated basal cell or squamous cell carcinoma 2. 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 3. A primary malignancy which has been completely resected and in complete remission for at least 2 years 11. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 12. 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. 13. Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year. 14. 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. 15. 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. 16. Has received: 1. Radiotherapy within 2 weeks of first administration of MT-302 2. Cytotoxic chemotherapy for treatment of the primary malignancy within 28 days or 5 half-lives, whichever is shorter, of administration of MT-302 3. 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 4. Targeted therapies for primary malignancy within 28 days or 5 half-lives, whichever is shorter, of first administration of MT-302 5. Anti-cancer vaccine within 12 weeks of first administration of MT-302 6. COVID-19 mRNA vaccine within 6 weeks of first administration of MT-302 17. Has received a live vaccine ≤ 6 weeks prior to first administration of MT-302 18. Has received packed red blood cells or platelet transfusion within 2 weeks prior to first administration of MT-302 19. History of an allergic reaction to any of the excipients 20. 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 21. 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.

Treatments Being Tested

DRUG

MT-302 (A)

MT-302 is an investigational drug

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Souther Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia
Cabrini Health
Malvern, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05969041), the sponsor (Myeloid Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05969041 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05969041?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05969041?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05969041. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05969041. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.