Actively Recruiting
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
Led by Myeloid Therapeutics · Updated on 2024-01-18
48
Participants Needed
6
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older at the time of signing informed consent
- Histologically confirmed metastatic or advanced epithelial cancer including urothelial, cervical, ovarian epithelial, triple-negative breast, HR+/HER2- breast, pancreatic ductal adenocarcinoma, gastric adenocarcinoma, esophageal carcinoma, non-small cell lung, or colorectal cancer
- Progressive disease at baseline, refractory or relapsed to standard care or declined standard therapy
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Echocardiogram or multiple gated acquisition scan showing ejection fraction ≥ 50%
- ECG without clinically significant abnormality or QTc interval < 450 msec in males and < 470 msec in females (< 480 msec with bundle branch block)
- Oxygen saturation ≥ 90% on room air by pulse oximetry
- Adequate organ function per laboratory values at screening
- Willing and able to provide written informed consent
- Willing to comply with all study procedures including biopsies and clinic visits
- Men must abstain from sperm donation during treatment and for 4 months after last dose
- Men and women of childbearing potential must use highly effective contraception
You will not qualify if you...
- Known active central nervous system metastasis or carcinomatous meningitis unless stable for ≥ 4 weeks without steroids for ≥ 14 days
- Pregnant or nursing women
- Within 28 days of major surgery including hepatectomy or joint replacement
- Prior allogeneic bone marrow or solid organ transplant
- Untreated spinal cord compression
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Acute illness or fever > 100.4°F (38°C) within 7 days before treatment start
- Active systemic bacterial, fungal, or viral infections within 7 days before treatment start
- Positive COVID-19 test within 7 days before treatment start
- Active HIV, hepatitis B, or hepatitis C infection
- Other primary malignancies except treated basal or squamous cell carcinoma, in situ carcinoma of cervix or bladder treated curatively without recurrence for ≥ 2 years, or fully resected primary malignancy in remission for ≥ 2 years
- History of pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Prior grade > 3 immune-related adverse events except dermatitis and endocrinopathies if stable
- Active autoimmune disease requiring systemic therapy within last year
- Symptomatic congestive heart failure (NYHA II-IV), serious arrhythmias, or significant cardiac disease within 12 months
- Unresolved toxicities from previous anticancer therapy above grade 1 except alopecia or listed labs
- Recent treatments: radiotherapy within 2 weeks, chemotherapy, immunotherapy, targeted therapies within 28 days or 5 half-lives, anticancer vaccine within 12 weeks, COVID-19 mRNA vaccine within 6 weeks
- Live vaccine within 6 weeks prior to treatment
- Blood transfusion within 2 weeks prior to treatment
- History of allergic reaction to study excipients
- Participation in another interventional trial within 28 days or 5 half-lives
- Any other condition making participation unsuitable or compliance impossible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
St Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
3
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
4
Souther Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
5
Cabrini Health
Malvern, Victoria, Australia, 3144
Actively Recruiting
6
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
S
Shinam Garg
CONTACT
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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