Hormone Sensitive Prostate Cancer
Conditions
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.
Interventions
DRUGSHR7280
Drug: SHR7280 All participants receive SHR7280 alone.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, Multicenter, Singel Group
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and the willingness to sign a written informed consent document； 2. Age ≥18 years old; 3. Histologically or cytologically confirmed prostate adenocarcinoma; 4. Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer； 5. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol； 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; 7. Adequate organ performance based on laboratory blood tests; 8. Agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion criteria
1. 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). 2. Patients who have received chemotherapy for prostate cancer; 3. History of surgical castration; 4. Received Abiraterone acetate with 3 months prior to the first dose of study drug; 5. 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; 6. Patients with known or suspected brain metastasis； 7. Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation; 8. Patients with uncontrolled and clinically significant hypertension and diabetes; 9. Known hypersensitivity to SHR7280, SHR7280 excipients,； 10. History of immunodeficiency (including HIV infection) or organ transplantation; 11. Known active hepatitis B or C infection; 12. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum testosterone concentrations | 30 days after last dose |
| Serum luteinizing hormone (LH) concentrations | 30 days after last dose |
| Serum follicle stimulating hormone (FSH) concentrations | 30 days after last dose |
| Time to Achieve Testosterone Concentrations < 50 ng/dL | 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 |
| Percentage of Participants With Effective Castration Rate Over 48 Weeks | Day 1 of Week 5 to Day 1 of Week 49 |
| 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 |
| Time to Prostate-Specific Antigen Progression | 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 |
| Maximum observed plasma concentration (Cmax) of SHR7280 | 30 days after last dose |
| Observed trough plasma concentration (Ctrough) of SHR7280 | 30 days after last dose |
| Time of maximum observed plasma concentration (Tmax) of SHR7280 | 30 days after last dose |
Countries
China
Outcome results
None listed