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A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

Primary Purpose

Prostate Cancer, Castration-resistant Prostate Cancer

Status

Terminated

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR3680

SHR2554

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Castration-resistant Prostate Cancer, SHR2554, SHR3680

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed prostate cancer;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
Radiographic evidence of metastasis;
Sustained therapy of luteinizing hormone-releasing hormone analogue（LHRHA）or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
Adequate hepatic, renal, heart, and hematological functions;
Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy;
Planned to initiate any other anti-tumor therapies during the study;
Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
Clinically significant cardiovascular diseases;
History of seizure or certain conditions that may predispose to seizure;
Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SHR2554

SHR2554+SHR3680

Arm Description

Participants will receive SHR2554 orally

Participants will receive SHR2554 combined with SHR3680 orally

Outcomes

Primary Outcome Measures

DLT

A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents

MTD

The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations

PSA response rate

After the continuous therapy from randomisation to the end of the 12 weeks, the ratio of patients whose levels of PSA decreased more than 50%

Secondary Outcome Measures

Time to PSA progression

Time from randomisation to the first time of PSA progression according to the criteria of the Prostate Cancer Clinical Trials Working Group 3 （PCWG3)

Objective response rate (ORR)

The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

Under the Curve (AUC)

The single dose and multiple dose PK will be calculated as data permits including Area AUC

Maximum Observed Plasma Concentration (Cmax)

The single-dose and multiple dose PK will be calculated as data permits including Cmax

Adverse events (AE)

The type, frequency, severity, timing, seriousness, and relationship to study therapy

Full Information

NCT ID

NCT03741712

First Posted

October 17, 2018

Last Updated

February 2, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03741712

Brief Title

A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

Official Title

A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

According to the available data from the trial，the sponsor determined to terminate this study.

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.

Detailed Description

This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Castration-resistant Prostate Cancer

Keywords

Castration-resistant Prostate Cancer, SHR2554, SHR3680

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR2554

Arm Type

Experimental

Arm Description

Participants will receive SHR2554 orally

Arm Title

SHR2554+SHR3680

Arm Type

Experimental

Arm Description

Participants will receive SHR2554 combined with SHR3680 orally

Intervention Type

Drug

Intervention Name(s)

SHR3680

Intervention Description

Tablet. Specifications of 80mg

Intervention Type

Drug

Intervention Name(s)

SHR2554

Intervention Description

Tablet. Specifications of 50mg and 200mg

Primary Outcome Measure Information:

Title

DLT

Description

A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents

Time Frame

Approximately 12 months

Title

MTD

Description

Time Frame

Approximately 12 months

Title

PSA response rate

Description

After the continuous therapy from randomisation to the end of the 12 weeks, the ratio of patients whose levels of PSA decreased more than 50%

Time Frame

Approximately 12 weeks

Secondary Outcome Measure Information:

Title

Time to PSA progression

Description

Time from randomisation to the first time of PSA progression according to the criteria of the Prostate Cancer Clinical Trials Working Group 3 （PCWG3)

Time Frame

Approximately 70 months

Title

Objective response rate (ORR)

Description

Time Frame

Approximately 70 months

Title

Under the Curve (AUC)

Description

The single dose and multiple dose PK will be calculated as data permits including Area AUC

Time Frame

Approximately 12 months

Title

Maximum Observed Plasma Concentration (Cmax)

Description

The single-dose and multiple dose PK will be calculated as data permits including Cmax

Time Frame

Approximately 12 months

Title

Adverse events (AE)

Description

The type, frequency, severity, timing, seriousness, and relationship to study therapy

Time Frame

Approximately 70 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed prostate cancer; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1; Radiographic evidence of metastasis; Sustained therapy of luteinizing hormone-releasing hormone analogue（LHRHA）or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA; Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy; Adequate hepatic, renal, heart, and hematological functions; Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy; Planned to initiate any other anti-tumor therapies during the study; Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases; History of seizure or certain conditions that may predispose to seizure; Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dingwei Ye, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

Country

China

12. IPD Sharing Statement

Learn more about this trial

A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

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