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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04995042
Collaborator
(none)
64
Enrollment
1
Location
1
Arm
25.2
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-label, Multicenter, Singel GroupOpen-label, Multicenter, Singel Group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
Actual Study Start Date :
Sep 24, 2021
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR7280 Does Escalation and Expansion

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

Outcome Measures

Primary Outcome Measures

  1. Adverse Events（AEs） [30 days after last dose]

  2. Dose Limited Toxicity (DLT) [28 Days (first cycle)]

  3. Maximum tolerable dose (MTD) [28 Days (first cycle）]

  4. Recommended dose for phase II (RP2D) [Up to 12 months]

Secondary Outcome Measures

  1. Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280 [30 days after last dose]

  2. Maximum observed plasma concentration (Cmax) of SHR7280 [30 days after last dose]

  3. Observed trough plasma concentration (Ctrough) of SHR7280 [30 days after last dose]

  4. Time of maximum observed plasma concentration (Tmax) of SHR7280 [30 days after last dose]

  5. Serum testosterone concentrations [30 days after last dose]

  6. Serum luteinizing hormone (LH) concentrations [30 days after last dose]

  7. Serum follicle stimulating hormone (FSH) concentrations [30 days after last dose]

  8. Time to Achieve Testosterone Concentrations < 50 ng/dL [30 days after last dose]

  9. Percentage of Participants With Effective Castration Rate Over 24 Weeks [Day 1 of Week 5 to Day 1 of Week 25]

  10. Percentage of Participants With Effective Castration Rate Over 48 Weeks [Day 1 of Week 5 to Day 1 of Week 49]

  11. 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]

  12. Time to Prostate-Specific Antigen Progression [30 days after last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04995042
Other Study ID Numbers:
  • SHR7280-104
First Posted:
Aug 6, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Hypersensitivity

Study Results

No Results Posted as of Jan 14, 2022