BridgeMD
New treatment option for Epithelial Tumors, Malignant
Official title Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
ClinicalTrials.gov ID: NCT05969041
What this study is testing
What is MT-302 (A)?
MT-302 (A) is an investigational medicine, being studied as a potential treatment for epithelial tumors, malignant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- Known active CNS metastasis and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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.
- 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...
- 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...
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Malvern, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Randwick, New South Wales, Australia; Westmead, New South Wales, Australia; Bedford Park, South Australia, Australia; Malvern, Victoria, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.