High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)Phase 1NCT06099990
Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
A Phase 1 study testing dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets in people with High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC), run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
- What is being tested?
- dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age of ≥ 18 years old,male
- ECOG PS score of 0 or 1；
- Prostate adenocarcinoma confirmed by histological。
- ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression
- Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration)
- Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent
Who cannot join
- Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
- Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy
- Confirmed by imaging, there are brain tumor foci
- History of severe lung disease such as interstitial pneumonia
- Plan to receive any other antitumor therapy during this trial
- Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).
This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment
- Being tested
- dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets, placebo; abiraterone acetate tablets; prednisone tablets
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tabletsDrug
dalpiciclib+ abiraterone+ prednisone
placebo; abiraterone acetate tablets; prednisone tabletsDrug
placebo+abirarerone+prenisone
| Study group | Role | What they receive |
|---|---|---|
| dalpiciclib+ abiraterone+ prednisone | Experimental | Not described Receives: Drug: dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets |
| placebo+abirarerone+prenisone | Placebo comparator | Not described Receives: Drug: placebo; abiraterone acetate tablets; prednisone tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) incidence
Measured: approximately 63 months
Secondary outcomes (5)
PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)
Measured: approximately 6 months
rPFS
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Measured: approximately 63 months
PSA response rate
In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week
Measured: approximately 63 months
ORR
Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses
Measured: approximately 63 months
Time to PSA progression
Time from randomisation to the first time of PSA progression
Measured: approximately 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
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
- NCT06099990
- Sponsor's protocol ID
- SHR6390-305
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 25 Oct 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 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).
- ClinicalTrials.gov ID
- NCT06099990
- Acronym / sponsor ID
- SHR6390-305
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Oct 2023 (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 study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dalpiciclib+ abiraterone+ prednisone | Experimental | Drug: dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets |
| placebo+abirarerone+prenisone | Placebo comparator | Drug: placebo; abiraterone acetate tablets; prednisone tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of ≥ 18 years old,male
- ECOG PS score of 0 or 1；
- Prostate adenocarcinoma confirmed by histological。
- ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression
- Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration)
Key exclusion criteria (6 listed)
- Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
- Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy
- Confirmed by imaging, there are brain tumor foci
- History of severe lung disease such as interstitial pneumonia
- Plan to receive any other antitumor therapy during this trial
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 |
|---|---|---|
| dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tabletsdalpiciclib+ abiraterone+ prednisone | Drug | dalpiciclib+ abiraterone+ prednisone |
| placebo; abiraterone acetate tablets; prednisone tabletsplacebo+abirarerone+prenisone | Drug | placebo+abirarerone+prenisone |
Primary outcome
Adverse event (AE) incidence
Time frame: approximately 63 months
5 secondary outcomes
PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)
Time frame: approximately 6 months
rPFS
Time frame: approximately 63 months
PSA response rate
Time frame: approximately 63 months
ORR
Time frame: approximately 63 months
Time to PSA progression
Time frame: approximately 63 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets in people with High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC), run by Jiangsu HengRui Medicine Co., Ltd..
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Liu (+86-18875033874, feng.liu.fl10@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (AE) incidence (time frame: approximately 63 months). 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 25 Oct 2023.