Phase 1 study
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| St Vincent's Public Hospital Sydney | Darlinghurst | NSW | Recruiting |
| Scientia Clinical Research Ltd | Randwick | NSW | Recruiting |
| Westmead Hospital | Westmead | NSW | Recruiting |
| Souther Oncology Clinical Research Unit (SOCRU) | Bedford Park | SA | Recruiting |
| Cabrini Health | Malvern | VIC | Recruiting |
| Linear Clinical Research Ltd | Nedlands | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 18 January 2024.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.