A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer

Hormone Sensitive Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995042
• Other study ID #: SHR7280-104
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: September 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 25, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hormone Sensitive Prostate Cancer
• Hypersensitivity
• Prostatic Neoplasms

Intervention

Drug:
• SHR7280
Drug: SHR7280 All participants receive SHR7280 alone.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events(AEs)		30 days after last dose
Primary	Dose Limited Toxicity (DLT)		28 Days (first cycle)
Primary	Maximum tolerable dose (MTD)		28 Days (first cycle)
Primary	Recommended dose for phase II (RP2D)		Up to 12 months
Secondary	Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280		30 days after last dose
Secondary	Maximum observed plasma concentration (Cmax) of SHR7280		30 days after last dose
Secondary	Observed trough plasma concentration (Ctrough) of SHR7280		30 days after last dose
Secondary	Time of maximum observed plasma concentration (Tmax) of SHR7280		30 days after last dose
Secondary	Serum testosterone concentrations		30 days after last dose
Secondary	Serum luteinizing hormone (LH) concentrations		30 days after last dose
Secondary	Serum follicle stimulating hormone (FSH) concentrations		30 days after last dose
Secondary	Time to Achieve Testosterone Concentrations < 50 ng/dL		30 days after last dose
Secondary	Percentage of Participants With Effective Castration Rate Over 24 Weeks		Day 1 of Week 5 to Day 1 of Week 25
Secondary	Percentage of Participants With Effective Castration Rate Over 48 Weeks		Day 1 of Week 5 to Day 1 of Week 49
Secondary	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
Secondary	Time to Prostate-Specific Antigen Progression		30 days after last dose