Clinical trial NCT04995042: A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
Official title: An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hormone Sensitive Prostate Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, Multicenter, Singel Group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events（AEs）
timeFrame: 30 days after last dose
measure: Dose Limited Toxicity (DLT)
timeFrame: 28 Days (first cycle)
measure: Maximum tolerable dose (MTD)
timeFrame: 28 Days (first cycle）
measure: Recommended dose for phase II (RP2D)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280
timeFrame: 30 days after last dose
measure: Maximum observed plasma concentration (Cmax) of SHR7280
timeFrame: 30 days after last dose
measure: Observed trough plasma concentration (Ctrough) of SHR7280
timeFrame: 30 days after last dose
measure: Time of maximum observed plasma concentration (Tmax) of SHR7280
timeFrame: 30 days after last dose
measure: Serum testosterone concentrations
timeFrame: 30 days after last dose
measure: Serum luteinizing hormone (LH) concentrations
timeFrame: 30 days after last dose
measure: Serum follicle stimulating hormone (FSH) concentrations
timeFrame: 30 days after last dose
measure: Time to Achieve Testosterone Concentrations < 50 ng/dL
timeFrame: 30 days after last dose
measure: Percentage of Participants With Effective Castration Rate Over 24 Weeks
timeFrame: Day 1 of Week 5 to Day 1 of Week 25
measure: Percentage of Participants With Effective Castration Rate Over 48 Weeks
timeFrame: Day 1 of Week 5 to Day 1 of Week 49
measure: Percentage of Serum Prostate-Specific Antigen Concentration Change frome Baseline at the End of Weeks 4, 8, 12
timeFrame: Day 1 of Weeks 5, 9 and 13
measure: Time to Prostate-Specific Antigen Progression
timeFrame: 30 days after last dose
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: