A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
- Registration Number
- NCT04995042
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Ability to understand and the willingness to sign a written informed consent document；
- Age ≥18 years old;
- Histologically or cytologically confirmed prostate adenocarcinoma;
- Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer；
- Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol；
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Adequate organ performance based on laboratory blood tests;
- Agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria
- Previously received gonadotropin-releasing hormone analogues (GnRH-a) for more than 12 months total duration (if GnRH-a was received for 12 months or less, then that GnRH-a must have been completed washout period prior to the first dose of study drug).
- Patients who have received chemotherapy for prostate cancer;
- History of surgical castration;
- Received Abiraterone acetate with 3 months prior to the first dose of study drug;
- Receieved molecular target therapy, immunotherapy, androgen receptor blockade, 5-alpha reductase inhibitors, estrogen, and other investigational compound with 4 weeks prior to the first dose of study drug;
- Patients with known or suspected brain metastasis；
- Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation;
- Patients with uncontrolled and clinically significant hypertension and diabetes;
- Known hypersensitivity to SHR7280, SHR7280 excipients,；
- History of immunodeficiency (including HIV infection) or organ transplantation;
- Known active hepatitis B or C infection;
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR7280 Does Escalation and Expansion SHR7280 -
- Primary Outcome Measures
Name Time Method Adverse Events（AEs） 30 days after last dose Dose Limited Toxicity (DLT) 28 Days (first cycle) Maximum tolerable dose (MTD) 28 Days (first cycle） Recommended dose for phase II (RP2D) Up to 12 months
- Secondary Outcome Measures
Name Time Method Time to Achieve Testosterone Concentrations < 50 ng/dL 30 days after last dose Time of maximum observed plasma concentration (Tmax) of SHR7280 30 days after last dose Serum testosterone concentrations 30 days after last dose Observed trough plasma concentration (Ctrough) of SHR7280 30 days after last dose Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280 30 days after last dose Serum luteinizing hormone (LH) concentrations 30 days after last dose Percentage of Participants With Effective Castration Rate Over 24 Weeks Day 1 of Week 5 to Day 1 of Week 25 Percentage of Serum Prostate-Specific Antigen Concentration Change frome Baseline at the End of Weeks 4, 8, 12 Day 1 of Weeks 5, 9 and 13 Maximum observed plasma concentration (Cmax) of SHR7280 30 days after last dose Time to Prostate-Specific Antigen Progression 30 days after last dose Serum follicle stimulating hormone (FSH) concentrations 30 days after last dose Percentage of Participants With Effective Castration Rate Over 48 Weeks Day 1 of Week 5 to Day 1 of Week 49
Trial Locations
- Locations (1)
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China