Phase I study of recombinant measles virus for Nectin-4 positive tumors

JRCT ID: jRCT2033210698

Registered date:26/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nectin-4 positive solid cancer
• Date of first enrollment: 06/09/2022
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Name:UT-MeV1
Dose:1 x 10^6, 1 x 10^7 or 1 x 10^8 TCID50
once a week, total 3 times

Outcome(s)

• Primary Outcome: Safety (Percentage of patients with dose limiting toxicity)

Secondary Outcome

-Response rate
-Overall survival
-Pharmacokinetics of the investigational product

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1. Patients with cancer who:
(1) Pathologically diagnosed as solid cancer.
(2) Immunohistochemically positive for Nectin-4.
(3) Recurrent cancer unresectable or with distant metastases.
(4) Unresponsive or intolerant to standard therapies.
(5) Tumor that is large enough for intratumoral administration of study product.
2. ECOG PS: 0-1.
3. Patients between the ages 18 and 75 at the time of consent.
4. Patients who meet specified values of laboratory tests for major organ function.
5. Patients who have an evaluable lesion by RECIST 1.1.
6. Written consent to participate in the trial.

Exclude criteria

1. Patients with HER2-positive breast cancer except for the patients who are refractory or intolerant to standard treatment with anti-HER2-targeting agents.
2. Major surgery or the last intervention of other clinical trial completed within 4 weeks of enrollment, drug therapy completed within 3 weeks of enrollment, or the last irradiation of radiation therapy completed within 2 weeks of enrollment.
3. Double cancer.
4. Complication or other general condition that is not appropriate to participate in the trial (e.g., infection, immunodeficiency, neurologic disease).
5. Interstitial lung disease or respiratory failure requiring oxygen.
6. HBV, HCV, or HIV infection.
7. Serious cardiovascular disease.
8. Metastases to brain or spinal cord.
9. Diabetes mellitus that is poorly controlled by drug administration.
10. History of hypersensitivity to any component of UT-MeV1 or any animal-derived component used in the manufacturing process of UT-MeV1.
11. Pregnancy, breast-feeding, or disagreement with appropriate contraception.
12. Patients who live with a pregnant woman or a person who has not received measles vaccination at the start of protocol therapy.
13. Patients who have a history of other viral therapy.
14. Patients who receive immunosuppressive agent or 10 mg or more dose of prednisolone.
15. Other case that is not appropriate to participate in the trial by the investigator.

Related Information

• Primary Sponsor: Takahashi Shunji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development