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Investigator-initiated phase 1 study of nucleic acid medicine targeting PRDM14 in patients with breast cancer

Investigator-initiated phase 1 study of nucleic acid medicine targeting PRDM14 in patients with breast cancer

Takahashi Shunji

Cancer Institute Hospital of JFCR

3-8-31, Ariake, Koto, Tokyo 135-8550, Japan

s.takahashi-chemotherapy@jfcr.or.jp

Goto Tatsushi

FiveRings Co., Ltd.

Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka, 530-0044, Japan

+81-6-6358-7110

gotou@fiverings.co.jp

Recruiting

Nov. 01, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients with breast cancer who:
*Pathologically diagnosed as breast cancer.
*Recurrent breast cancer unresectable or with distant metastases that is indicated for systemic chemotherapy.
*ECOG PS: 0-1.
*Female between the ages 20 and 75 at the time of consent.
*History of 2 or more types of chemotherapy including anthracyclines and taxanes, as adjuvant therapy, neoadjuvant therapy or chemotherapy for metastasis or recurrence.
2. Meet specified values of laboratory tests for major organ function.
3. Expect to survive for at least 3 months from the date of enrollment.
4. Have an evaluable lesion by RECIST 1.1.
5. Written consent to participate in the trial.

1. HER2 positive
2. Major surgery or the last intervention of other clinical trial completed within 4 weeks of enrollment, chemotherapy or endocrine 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. Pulmonary fibrosis or respiratory failure requiring oxygen.
6. HBV, HCV, or HIV infection.
7. Serious cardiovascular disease.
8. Metastases brain or spinal cord.
9. Diabetes mellitus that is poorly controlled by drug administration.
10. Allergy related to a substance contained in the investigational drug or a substance involved in the manufacture.
11. Pregnancy, breast-feeding, or disagreement with appropriate contraception.
12. Other case that is not appropriate to participate in the trial by the investigator.

Female

breast cancer

SRN-14/GL2-800 mixture administered weekly.

safety

1.Efficacy by tumor shrinkage, 2.Pharmacokinetics

No

none