Primary Outcome Measures: | |
1. |
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) [ Time Frame: Day 1 up to approximately 3 years ]
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Secondary Outcome Measures: | |
1. |
Number of Participants with a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to approximately 3 years ]
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2. |
Number of Participants with an Adverse Event of Special Interest (AESI) [ Time Frame: Day 1 up to approximately 3 years ]
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3. |
Immune ORR (iORR) According to RECIST for immune-based therapeutics (iRECIST) [ Time Frame: Day 1 up to approximately 3 years ]
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4. |
Best Overall Response (BOR) According to RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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5. |
Immune BOR (iBOR) According to iRECIST [ Time Frame: Day 1 up to approximately 3 years ]
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6. |
Duration of Response (DoR) According to RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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7. |
Immune DoR (iDoR) According to iRECIST [ Time Frame: Day 1 up to approximately 3 years ]
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8. |
Clinical Benefit Rate (CBR) According to RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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9. |
Immune CBR (iCBR) According to iRECIST [ Time Frame: Day 1 up to approximately 3 years ]
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10. |
Progression-free Survival (PFS) According to RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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11. |
Immune PFS (iPFS) According to iRECIST [ Time Frame: Day 1 up to approximately 3 years ]
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12. |
Time to Response (TtR) According to RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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13. |
Immune TtR (iTtR) According to iRECIST [ Time Frame: Day 1 up to approximately 3 years ]
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14. |
Metastatic Castration-resistant Prostate Cancer (mCRPC) only: DoR as Assessed According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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15. |
mCRPC only: CBR as Assessed According to PCWG3-modified RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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16. |
mCRPC only: PFS as Assessed According to PCWG3-modified RECIST 1.1 [ Time Frame: Day 1 up to approximately 3 years ]
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17. |
mCRPC only: Circulating Tumor Cell (CTC) Count Conversion as Assessed According to PCWG3-modified RECIST 1.1 [ Time Frame: Day 1 up to approximately 2 years ]
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18. |
mCRPC only: Confirmed Prostate-specific Antigen (PSA) Decline of ≥50% as Assessed According to PCWG3-modified RECIST 1.1 [ Time Frame: Day 1 up to approximately 2 years ]
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19. |
mCRPC only: Time to Confirmed PSA Progression as Assessed According to PCWG3-modified RECIST 1.1 [ Time Frame: Day 1 up to approximately 2 years ]
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20. |
SOT101 Plasma Concentration Profile at Various Timepoints [ Time Frame: Cycle 1 Day 1 to Cycle 3 Day 1 (up to approximately 9 weeks, where each cycle is 3 weeks) ]
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21. |
Number of Participants with Anti-drug Antibodies (ADAs) [ Time Frame: Day 1 up to approximately 2 years ]
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