This study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy
Age ≥18 years.
Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrent metastasis (such as in the bladder, rectum, etc.) cannot be included.
Testosterone levels ≤50ng/dL (≤1.75nmol/L) within 28 days prior to the first administration. If the patient has not undergone bilateral orchiectomy in the past, they must be undergoing and voluntarily continue to receive LHRH agonists/antagonists for androgen deprivation therapy throughout the study treatment period
During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA > 1ng/ml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.
Received CDK4/6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib/G1T38, SHR6390, pirociclib) ;
Received abirone acetate tablets and their analogues (CYP17 inhibitors, such as ketoconazole, etc.) or two or more novel endocrine therapies for prostate cancer;
Received with strontium-89, samarium or radium-223 within 12 weeks prior to the first administration;
Received systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) within 4 weeks prior to the first medication;
Single group
TY-302
DrugTake the specified dose (75mg or 100mg) orally once a day. Take it on an empty stomach in the morning with about 200 mL of warm water.
Abiraptor
DrugTake orally, 1000mg each time, once a day. Take it on an empty stomach in the morning with warm water, or take it orally at least two hours after fasting.
(Escalation stage) Dose Limiting Toxicity (DLT)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.
Maximum tolerated dose（MTD）
To determine the maximum tolerated dose for combination-agent escalation.
(Escalation stage) Recommended Phase 2 Dose（RP2D）
The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy collected during the dose escalation portion of the study
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Prostate-specific antigen (PSA) response rate
The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria.
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Duration of response (DOR)
DOR is defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG is the appearance of \>2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for \>6 weeks.
Objective response rate (ORR)
The ORR is defined as the percentage of participants with complete response (CR: disappearance of all target lesions per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); and no evidence of disease (NED) on base scan per Prostate Cancer Working Group (PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable \[NE\], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
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