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

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

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

Study Overview

• Status: Completed
• Conditions: Hormone Sensitive Prostate Cancer
• Intervention / Treatment: Drug: SHR7280

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR7280 Does Escalation and Expansion	Drug: SHR7280; Drug: SHR7280 All participants receive SHR7280 alone.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280	30 days after last dose
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
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
Percentage of Participants With Effective Castration Rate Over 24 Weeks	Day 1 of Week 5 to Day 1 of Week 25
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypersensitivity; Prostatic Neoplasms
• Other Study ID Numbers: SHR7280-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No