Advanced solid cancers, HER2-negative recurrent or metastatic breast cancer
Conditions
Interventions
PT0101 will be administered twice every 14 days. In principle, 4 weeks (28 days) will be regarded as 1 cycle. PT0101 will be administered for a maximum of 6 cycles, unless patients meet the criteria f
Sponsors
Shimazu Kenzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have voluntarily provided written informed consent for participation in the study 2. Patients aged 18 years or older at the time of providing informed consent 3. No standard treatment or completed standard treatment (refractory or intolerant to standard treatment) 4. Patients with pathologically (histologically or cytologically) diagnosed as solid tumor, also with unresectable local lesion or metastatic lesion 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1 6. 30 days or more have passed since the last dose of anti-tumor agents (including any investigational product) at the time of enrollment, 60 days or more have passed since the last dose of immune checkpoint inhibitors at the time of enrollment, safety requirements at the time of enrollment should be confirmed in accordance with Inclusion Criterion (8) 7. 21 days or more have passed since the last irradiation of radiation therapy at the time of enrollment 8. Patients who have AEs due to previous anticancer therapies must have recovered to Grade = 1,500/mm3 (growth factor independent) -Platelets >= 100,000/mm3 (growth factor or transfusion independent) -Hemoglobin >= 9g/dL (growth factor or transfusion independent) 10. Patients must have following adequate liver function: -Bilirubin = 3.0 g/dL 11. Patients must have following adequate kidney function: -eGFR>=40 mL/min/1.73 m2 12. Patients can be taken intervenous accesses (including central venous catheter ports) suitable for the collection of blood samples required for the study, including for pharmacokinetic evaluation 1. Patients who have voluntarily provided written informed consent for participation in the study 2. Patients aged 18 years or older at the time of providing informed consent 3. No standard treatment or completed standard treatment(refractory or intolerant to standard treatment) 4. Patients with pathologically (histologically or cytologically) diagnosed as solid tumor, also with unresectable local lesion or metastatic lesion 5. Patient with ECOG PS 0 or 1 6. 30 days or more have passed since the last dose of anti-tumor agents (including any investigational product) at the time of enrollment, 60 days or more have passed since the last dose of immune checkpoint inhibitors at the time of enrollment, safety requirements at the time of enrollment should be confirmed in accordance with Inclusion Criterion (8) 7. 21 days or more have passed since the last irradiation of radiation therapy at the time of enrollment 8. Patients who have AEs due to previous anticancer therapies must have recovered to Grade <=1 according to CTCAE v5.0, except for chronic toxicities considered to have stable symptoms by the investigator, such as alopecia, Grade 2 autoimmune diseases with stable symptoms controlled by replacement therapy, and Grade 2 hypertension that can be controlled 9. Patients must have following adequate bone marrow function: -Neutrophil cou
Exclusion criteria
Exclusion criteria: 1. Patients with interstitial lung disease/pneumonitis (including radiation pneumonitis) 2. Patients with primary brain tumors or central nervous system metastases, either active or inactive 3. Patients with multiple cancers (simultaneous or metachronous with disease-free interval of 2 years or less from the registration date), except for carcinoma in situ and non-invasive cancers 4. Patients with active infection requiring systemic treatment 5. Patients who are positive for HBV, HCV, or HIV 6. Patients with heart failure Class II -IV according to NYHA Classification, or history of heart failure Class III or IV according to NYHA Classification 7. Patients who have a history or complication of ischemic heart disease, arrhythmias requiring treatment 8. Patients who have a history or complication of cerebrovascular or cardiovascular impairment, thromboembolism, or sudden cardiac arrest, requiring treatment 9. Patients with uncontrolled diabetes mellitus 10. Patients with uncontrolled hypertension (over systolic blood pressure 160mmHg and diastolic blood pressure 100mmHg) 11. Patients with pleural effusion, ascites, or pericardial effusion requiring regular drainage 12. Women of childbearing potential (i.e., those who have not undergone permanent sterilization and are premenopausal) who intend to become pregnant, pregnancy, lactation. Patients judged to be pregnant by investigator are ineligible because it is possible that a pregnancy test may not show a positive result in early pregnancy. 13. Patients with a history of hypersensitivity to PT0101 14. Patients with highly invasive surgical intervention within 14 days prior to entry 15. Patients who are receiving any investigational study or interventional clinical study, or who are planning to join any other study during this study 16. Patients who are deemed by the investigator to be inappropriate to participate in this study 1. Patients with interstitial lung disease/pneumonitis (including radiation pneumonitis) 2. Patients with primary brain tumors or central nervous system metastases, either active or inactive 3. Patients with multiple cancers (simultaneous or metachronous with disease-free interval of 2 years or less from the registration date), except for carcinoma in situ and non-invasive cancers 4. Patients with active infection requiring systemic treatment 5. Patients who are positive for HBV, HCV, or HIV 6. Patients with heart failure Class II -IV according to NYHA Classification, or history of heart failure Class III or IV according to NYHA Classification 7. Patients who have a history or complication of ischemic heart disease, arrhythmias requiring treatment 8. Patients who have a history or complication of cerebrovascular or cardiovascular impairment, thromboembolism, or sudden cardiac arrest, requiring treatment 9. Patients with uncontrolled diabetes mellitus 10. Patients with uncontrolled hypertension (over systolic blood pressure 160mmHg and diastolic blood pressure 100mmHg) 11. Patients with pleural effusion, ascites, or pericardial effusion requiring regular drainage 12. Women of childbearing potential (i.e., those who have not undergone permanent sterilization and are premenopausal) who intend to become pregnant, pregnancy, lactation. Patients judged to be pregnant by investigator are ineligible because it is possible that a pregnancy test may not show a positive result in early pregnancy. 13. Patients with hig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse events and their frequencies that occurred with each dose when PT0101 is administered as a single agent. -DLT of PT0101 administered as a single agent -MTD of PT0101 administered as a single agent -Adverse events and their frequencies that occurred with each dose when PT0101 is administered in combination with paclitaxel. -DLT of PT0101 administered in combination with paclitaxel -MTD of PT0101 administered in combination with paclitaxel -Response rate of PT0101 in combination with paclitaxel as assessed by the physician acccording to RECIST v1.1. (complete response:CR, partial response:PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Overall survival and its rate -Progression-free survival Response ratio (CR, PR) assessed by the physician according to RECIST v1.1. -Disease control rate (CR, PR, stabe disease:SD) assessed by the physician according to RECIST v1.1. -Changes in blood concentration of PT0101 by dose -Changes in blood Periostin concentration by dose -Changes in tumor marker by dose (Change from baseline) -Changes in pharmacodynamic markers by dose (Change from baseline) -Disease control rate (CR, PR, SD) assessed by the physician according to RECIST v1.1. -Overall survival and its rate -Progression-free survival -Changes in blood concentration of PT0101 by dose -Changes in blood Periostin concentration by dose -Changes in tumor marker by dose (Change from baseline) -Changes in pharmacodynamic markers by dose (Change from baseline) | — |
Contacts
Public ContactTetsuhiro Yoshinami
The University of Osaka Hospital
Outcome results
None listed