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

NCT04995042 | Completed Phase 1

• 1 other identifier: SHR7280-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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

Study Arms (1)

SHR7280 Does Escalation and Expansion

EXPERIMENTAL

Drug: SHR7280

Interventions

SHR7280 DRUG

Drug: SHR7280 All participants receive SHR7280 alone.

SHR7280 Does Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document；
• Age ≥18 years old;
• Histologically or cytologically confirmed prostate adenocarcinoma;
• Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer；
• Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol；
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
• Adequate organ performance based on laboratory blood tests;
• Agree to use adequate contraception prior to study entry and for the duration of study participation.

You may not qualify if:

• 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).
• Patients who have received chemotherapy for prostate cancer;
• History of surgical castration;
• Received Abiraterone acetate with 3 months prior to the first dose of study drug;
• 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;
• Patients with known or suspected brain metastasis；
• Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation;
• Patients with uncontrolled and clinically significant hypertension and diabetes;
• Known hypersensitivity to SHR7280, SHR7280 excipients,；
• History of immunodeficiency (including HIV infection) or organ transplantation;
• Known active hepatitis B or C infection;
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, Multicenter, Singel Group

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: September 24, 2021
• Primary Completion: May 24, 2023
• Study Completion: May 25, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)