Hormone Sensitive Prostate CancerPhase 1NCT04995042
A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
A Phase 1 study testing SHR7280 in people with Hormone Sensitive Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Sensitive Prostate Cancer
- What is being tested?
- SHR7280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2021to 25 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: 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.
- Conditions
- Hormone Sensitive Prostate Cancer
- Being tested
- SHR7280
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR7280Drug
Drug: SHR7280 All participants receive SHR7280 alone.
| Study group | Role | What they receive |
|---|---|---|
| SHR7280 Does Escalation and Expansion | Experimental | Not described Receives: Drug: SHR7280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events（AEs）
Measured: 30 days after last dose
Dose Limited Toxicity (DLT)
Measured: 28 Days (first cycle)
Maximum tolerable dose (MTD)
Measured: 28 Days (first cycle）
Recommended dose for phase II (RP2D)
Measured: Up to 12 months
Secondary outcomes (12)
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280
Measured: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR7280
Measured: 30 days after last dose
Observed trough plasma concentration (Ctrough) of SHR7280
Measured: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR7280
Measured: 30 days after last dose
Serum testosterone concentrations
Measured: 30 days after last dose
Serum luteinizing hormone (LH) concentrations
Measured: 30 days after last dose
Serum follicle stimulating hormone (FSH) concentrations
Measured: 30 days after last dose
Time to Achieve Testosterone Concentrations < 50 ng/dL
Measured: 30 days after last dose
Percentage of Participants With Effective Castration Rate Over 24 Weeks
Measured: Day 1 of Week 5 to Day 1 of Week 25
Percentage of Participants With Effective Castration Rate Over 48 Weeks
Measured: 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
Measured: Day 1 of Weeks 5, 9 and 13
Time to Prostate-Specific Antigen Progression
Measured: 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start24 Sep 2021
- Primary completion24 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, Multicenter, Singel Group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995042
- Sponsor's protocol ID
- SHR7280-104
- Status last verified
- Sep 2023
- First submitted
- 29 Jul 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT04995042
- Acronym / sponsor ID
- SHR7280-104
- Conditions
- Hormone Sensitive Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, Multicenter, Singel Group
| Arm | Type | Receives |
|---|---|---|
| SHR7280 Does Escalation and Expansion | Experimental | Drug: SHR7280 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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；
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR7280Drug: SHR7280 All participants receive SHR7280 alone. | Drug | SHR7280 Does Escalation and Expansion |
Primary outcome
Adverse Events（AEs）
Time frame: 30 days after last dose
Dose Limited Toxicity (DLT)
Time frame: 28 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 28 Days (first cycle）
Recommended dose for phase II (RP2D)
Time frame: Up to 12 months
12 secondary outcomes
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280
Time frame: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR7280
Time frame: 30 days after last dose
Observed trough plasma concentration (Ctrough) of SHR7280
Time frame: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR7280
Time frame: 30 days after last dose
Serum testosterone concentrations
Time frame: 30 days after last dose
Serum luteinizing hormone (LH) concentrations
Time frame: 30 days after last dose
Serum follicle stimulating hormone (FSH) concentrations
Time frame: 30 days after last dose
Time to Achieve Testosterone Concentrations < 50 ng/dL
Time frame: 30 days after last dose
Percentage of Participants With Effective Castration Rate Over 24 Weeks
Time frame: Day 1 of Week 5 to Day 1 of Week 25
Percentage of Participants With Effective Castration Rate Over 48 Weeks
Time frame: 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
Time frame: Day 1 of Weeks 5, 9 and 13
Time to Prostate-Specific Antigen Progression
Time frame: 30 days after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR7280 in people with Hormone Sensitive Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events（AEs） (time frame: 30 days after last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.