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

NCT ID: NCT04995042

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-24
• Study Completion Date: 2023-05-25

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.

Conditions

Hormone Sensitive Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR7280 Does Escalation and Expansion

Group Type: EXPERIMENTAL

SHR7280

Intervention Type: DRUG

Drug: SHR7280 All participants receive SHR7280 alone.

Interventions

SHR7280

Drug: SHR7280 All participants receive SHR7280 alone.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

SHR7280-104

Identifier Type: -

Identifier Source: org_study_id