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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05969041




Registration number
NCT05969041
Ethics application status
Date submitted
6/07/2023
Date registered
1/08/2023
Date last updated
18/01/2024

Titles & IDs
Public title
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
Scientific 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
Secondary ID [1] 0 0
MTX-TROP2-302
Universal Trial Number (UTN)
Trial acronym
MYE Symphony
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Tumors, Malignant 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MT-302 (A)

Experimental: A (MT-302) - Participants will receive MT-302 through intravenous infusion.


Treatment: Drugs: MT-302 (A)
MT-302 is an investigational drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events
Timepoint [1] 0 0
Up to Week 20
Primary outcome [2] 0 0
To establish the maximum tolerated dose (MTD)
Timepoint [2] 0 0
Up to Week 20
Secondary outcome [1] 0 0
To further characterize the safety of MT-302 through incidence of Adverse Events
Timepoint [1] 0 0
Up to Week 20
Secondary outcome [2] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [2] 0 0
Up to Week 20
Secondary outcome [3] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [3] 0 0
Up to Week 20
Secondary outcome [4] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [4] 0 0
Up to Week 20
Secondary outcome [5] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [5] 0 0
Up to Week 20
Secondary outcome [6] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [6] 0 0
Up to Week 20
Secondary outcome [7] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [7] 0 0
Up to Week 20
Secondary outcome [8] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [8] 0 0
Up to Week 20
Secondary outcome [9] 0 0
To assess the pharmacokinetics (PK) of MT-302
Timepoint [9] 0 0
Up to Week 20
Secondary outcome [10] 0 0
Determine rate of ICANS
Timepoint [10] 0 0
Up to Week 20
Secondary outcome [11] 0 0
Determine rate of Grade 3-5 CRS
Timepoint [11] 0 0
Up to Week 20

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2028
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Public Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Souther Oncology Clinical Research Unit (SOCRU) - Bedford Park
Recruitment hospital [5] 0 0
Cabrini Health - Malvern
Recruitment hospital [6] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Myeloid Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05969041
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew Maurer, MD
Address 0 0
Myeloid Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shinam Garg
Address 0 0
Country 0 0
Phone 0 0
+61 2 9171 3260
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05969041