RU2020137434A - CANCER TREATMENT - Google Patents

Claims (39)

1. A method of treating cancer in a patient in need of such treatment, comprising administering to the patient a therapeutically effective amount of a compound of formula 1

, wherein the compound forms a complex with the metal. 2. The method of claim 1, wherein the cancer is a PSMA-expressing cancer. 3. The method of claim 1, wherein the compound of formula 1 is at least about 98% pure. 4. The method according to claim 1, wherein the cancer is prostate cancer or metastatic castration-resistant prostate cancer. 5. The method according to any one of the preceding claims, characterized in that the compound of formula 1 is administered in a parenteral dosage form. 6. The method according to claim 5, characterized in that the parenteral dosage form is selected from the group consisting of forms for intradermal, subcutaneous, intramuscular, intraperitoneal, intravenous and intrathecal administration. 7. The method according to any one of paragraphs. 1-4, characterized in that the therapeutically effective amount is from about 2 GBq to about 13 GBq, or from about 4 GBq to about 11 GBq, or from about 5 GBq to about 10 GBq, or from about 6 GBq to about 9 GBq , from about 6.5 GBq to about 8.5 GBq, or from about 7 GBq to about 8 GBq. 8. The method according to any one of paragraphs. 1-4, characterized in that the therapeutically effective amount is about 7.4 GBq. 9. The method according to any one of paragraphs. 1-4, further including visualization of PSMA expression in cancer. 10. The method according to claim 9, characterized in that the imaging is carried out before the injection step. 11. The method of claim. 10, characterized in that the imaging is performed by imaging, and the imaging is selected from the group consisting of SPECT imaging, PET imaging, IHC and FISH. 12. The method according to claim 11, characterized in that the imaging is performed using SPECT imaging. 13. The method according to any one of paragraphs. 1-4, further comprising determining the patient's PSMA status from the imaging data. 14. The method according to claim 13, wherein the visualization is a SPECT visualization. 15. The method of claim 14, wherein the patient's PSMA status correlates with clinical benefit to the patient. 16. The method of claim 15 wherein the clinical benefit is selected from the group consisting of tumor growth inhibition, stable disease, partial response, and complete response. 17. The method of claim 16 wherein the clinical benefit is a stable disease. 18. The method of claim 16, wherein at least one PSMA-positive lesion is indicative of a functionally active PSMA. 19. The method according to any one of paragraphs. 1-4, characterized in that the patient has been treated with at least one previous treatment. 20. The method of claim 19, wherein at least one prior treatment is selected from the group consisting of systemic treatment of the androgen axis, a chemotherapeutic agent, surgery, radiation therapy, immunotherapy, photodynamic therapy, stem cell therapy, and hyperthermia. 21. The method of claim 20 wherein at least one prior treatment is a systemic drug treatment of the androgen axis. 22. The method of claim 20 wherein at least one prior treatment is selected from the group consisting of abiraterone, orteronel, galeterone, seviteronel, apalutamide, enzalutamide, and combinations thereof. 23. The method of claim 19, wherein at least one prior treatment is selected from the group consisting of palyphosphamide, 5-fluorouracil, capecitabine, pemetrexed, cisplatin, carboplatin, gemcitabine, paclitaxel, vinorelbine, eribulin, docetaxel, cyclophosphamide, doxorubicin, regorafenib and combinations thereof. 24. The method according to any one of paragraphs. 1-4, characterized in that the compound of formula 1 is administered in combination with the second treatment. 25. The method of claim 24, wherein the second treatment is the best maintenance treatment. 26. The method of claim 24, wherein the second treatment is the best standard treatment. 27. The method of claim 24 wherein the second treatment is the best maintenance/best standard of care. 28. The method of claim 24 wherein the second treatment is a systemic treatment of the androgen axis. 29. The method of claim 28 wherein the systemic treatment of the androgen axis is selected from the group consisting of abiraterone, orteronel, galeterone, seviteronel, apalutamide, enzalutamide, and combinations thereof. 30. The method of claim 24, wherein the second treatment is radiation therapy. 31. The method of claim 24, wherein the radiation therapy is external beam radiation therapy (EBRT). 32. The method according to any one of paragraphs. 1-4, characterized in that the compound of formula 1 is administered on a schedule once a week, or once every 2 weeks, or once every 3 weeks, once every 4 weeks, or once every 5 weeks, or once every 6 weeks, or once every 7 weeks, or once every 8 weeks. 33. The method according to any one of paragraphs. 1-32, characterized in that the compound of formula 1 is administered on a schedule once every 4-6 weeks. 34. The method according to any one of paragraphs. 32 or 33, characterized in that the compound of formula 1 is administered for about 2-8 cycles of this schedule, or about 3-7 cycles of this schedule, about 4-6 cycles of this schedule. 35. The method according to any one of the preceding claims, characterized in that the metal is selected from the group consisting of ⁹⁰ Y, ¹⁷⁷ Lu, ⁶⁴ Cd, ¹⁵³ Gd, ¹⁵⁵ Gd, ¹⁵⁷ Gd, ²¹³ Bi and ²²⁵ Ac. 36. The method according to p. 35, characterized in that the metal is ¹⁷⁷ Lu. 37. The method according to p. 35, characterized in that the metal is ²²⁵ Ac.