Trial Title:
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
NCT ID:
NCT05969041
Condition:
Epithelial Tumors, Malignant
Conditions: Official terms:
Neoplasms, Glandular and Epithelial
Carcinoma
Conditions: 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)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MT-302 (A)
Description:
MT-302 is an investigational drug
Arm group label:
A (MT-302)
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Vincent's Public Hospital Sydney
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Rasha Cosman, MD
Facility:
Name:
Scientia Clinical Research Ltd
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Charlotte Lemech, MD
Investigator:
Last name:
Charlotte Lemech, MD
Email:
Principal Investigator
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Adnan Nagrial
Investigator:
Last name:
Adnan Nagrial, MD
Email:
Principal Investigator
Facility:
Name:
Souther Oncology Clinical Research Unit (SOCRU)
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Ganessan Kichendasse, MD
Facility:
Name:
Cabrini Health
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Gary Richardson, MD
Phone:
0395089542
Investigator:
Last name:
Gary Richardson, MD
Email:
Principal Investigator
Facility:
Name:
Linear Clinical Research Ltd
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Timothy Humphries, MD
Start date:
August 2, 2023
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Myeloid Therapeutics
Agency class:
Industry
Source:
Myeloid Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05969041
