NCT07871110
Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Recruiting · Phase 2 · TransThera Sciences (Nanjing), Inc. · registry updated 2026-10-13
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The goal of this clinical trial is to learn if tinengotinib combined with darolutamide or enzalutamide works to treat participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor pathway inhibitors (ARPIs). It will also learn about the safety of the combination therapy. The main questions it aims to answer are: 1. If participants with mCRPC can benefit from the combination therapy of tinengotinib plus one ARPI? 2. What medical problems do participants have when taking the combination therapy? Participants will take tinengotinib with darolutamide or enzalutamide to find the optimal dose and regimen of tinengotinib for the combination therapy in stage A. In stage B, participants will take preferred combination regimen of tinengotinib plus darolutamide/enzalutamide identified in stage A. In stage C, researchers will compare selected combination therapy versus standard treatment and/or monotherapy to see if the combination therapy works better.
Inclusion
- Male aged \>= 18 years at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed prostate adenocarcinoma; neuroendocrine differentiation after prior treatment is permitted (patients with de novo neuroendocrine prostate cancer at initial diagnosis are excluded).
- Baseline imaging confirming metastatic lesions in bone (\>=2 bone lesions) or soft tissue; lesions identified only by PET imaging are not acceptable.
- Receipt of continuous medical castration for \>=90 days or prior surgical castration, with serum testosterone \< 50 ng/dL (1.73 nmol/L) within 28 days prior to the first dose. Participants receiving medical castration with a luteinizing hormone-releasing hormone (LHRH) analogue must continue treatment throughout the study.
- Documented disease progression (per RECIST v1.1 and/or PCWG3) after \>1 month of prior novel endocrine therapy (including abiraterone and AR inhibitors).
- Cohort B: Prior exposure to only one type of novel endocrine therapy.
Exclusion
- Prior treatment with tyrosine kinase inhibitors (TKIs).
- Prior treatment with darolutamide or enzalutamide (except for treatment duration \<= 1 month).
- Uncontrolled hypertension (systolic blood pressure \>=150 mmHg or diastolic blood pressure \>=100 mmHg; repeat measurement is permitted after an interval of \>=10 minutes if abnormal), or a medical history of hypertensive crisis/hypertensive encephalopathy. Uncontrolled is defined as failure to achieve blood pressure control despite antihypertensive therapy with stable type/dose for at least 1 week.
- Concurrent central nervous system (CNS) metastases with radiological or symptomatic progression within 28 days prior to study treatment initiation.
- Concurrent other malignancies requiring active treatment. Malignancies not requiring treatment within 5 years and cured localized tumors such as basal cell carcinoma of the skin, papillary thyroid carcinoma, etc., are excluded from this criterion.
- Prior administration of other anti-tumor therapies within \<=5 half-lives or 14 days (whichever is shorter) before initiation of study treatment, or failure to recover from adverse events of prior therapy (except for adverse events \<= Grade 1 or \<= Grade 2 adverse events judged by the investigator not to pose a safety risk). Sex hormone therapies other than LHRH agents must be discontinued \>=7 days before study drug administration.