Prostatic NeoplasmsPhase 1NCT05295927
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 1 study testing EPI-7386, Abiraterone Acetate and Prednisone or Prednisolone in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 4 sites in 2 countries.
Trial summary
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- EPI-7386, Abiraterone Acetate and Prednisone or Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Mar 2022to 30 Sep 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate adenocarcinoma
- Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
- Must be able to swallow oral medicines
- Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Who cannot join
- Known central nervous system (CNS) metastases
- Non-metastatic castration-resistant prostate cancer (CRPC) (biochemical or locoregional disease only) is excluded from trial participation
- Evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s)
- Symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease
- Known disorder affecting gastrointestinal absorption
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
GU Research Network
Omaha, Nebraska, 68130
Chesapeake Urology Research Associates
Towson, Maryland, 21204
About this study
Official title: A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study)
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
- Conditions
- Prostatic Neoplasms
- Being tested
- EPI-7386, Abiraterone Acetate, Prednisone or Prednisolone, Apalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-7386Drug
EPI-7386 will be administered orally once daily.
Abiraterone AcetateDrug
Abiraterone Acetate will be administered orally once daily.
Prednisone or PrednisoloneDrug
Prednisone or Prednisolone will be administered orally twice daily.
ApalutamideDrug
Apalutamide will be administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP) | Experimental | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP. Receives: Drug: EPI-7386; Drug: Abiraterone Acetate; Drug: Prednisone or Prednisolone |
| Group B: EPI-3786 + Apalutamide | Experimental | Participants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide. Receives: Drug: EPI-7386; Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 3 Years 3 Months
Number of Participants with AEs by Severity
Number of participants with AEs by severity will be reported.
Measured: Up to 3 Years 3 Months
Number of Participants with Dose-limiting Toxicities (DLT)
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Measured: Up to 28 days of Cycle 1 (each cycle of 28 days)
Composite Response Rate
Composite response rate at 12 weeks, defined as either 90 percent (%) reduction in prostate-specific antigen (PSA) level from baseline (PSA-90), or objective response (confirmed per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in participants with measurable disease, or both at 12 weeks.
Measured: At 12 weeks
Secondary outcomes (13)
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Abiraterone
Cmax is defined as the maximum observed serum concentration of EPI-7386 and abiraterone.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and Abiraterone
Tmax is defined as the time to reach maximum observed serum concentration of EPI-7386 and abiraterone.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Abiraterone
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of EPI-7386 and abiraterone.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Abiraterone
Cmin is the minimum observed serum concentration of EPI-7386 and abiraterone.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Abiraterone
The observed accumulation ratio for Cmax, determined after multiple dose administration of EPI-7386 and abiraterone (Cycle[C] 2 Day[D] 1/C1D1 and C3D1/C1D1).
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Abiraterone
The observed accumulation ratio for AUCtau, determined after multiple dose administration of EPI-7386 and abiraterone (C2D1/C1D1 and C3D1/C1D1).
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Apalutamide
Cmax is defined as the maximum observed serum concentration of EPI-7386 and apalutamide.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and apalutamide
Tmax is defined as the time to reach maximum observed serum concentration of EPI-7386 and apalutamide.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Apalutamide
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of EPI-7386 and apalutamide.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Apalutamide
Cmin is the minimum observed serum concentration of EPI-7386 and apalutamide.
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Apalutamide
The observed accumulation ratio for Cmax, determined after multiple dose administration EPI-7386 and apalutamide (C2D1/C1D1 and C3D1/C1D1).
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Apalutamide
The observed accumulation ratio for AUCtau, determined after multiple dose administration EPI-7386 and Apalutamide (C2D1/C1D1 and C3D1/C1D1).
Measured: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Serum Prostate-Specific Antigen (PSA)
Serum PSA concentration will be measured.
Measured: Up to 3 Years 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start23 Mar 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: Administrative Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295927
- Sponsor's protocol ID
- CR109122
- Other IDs
- 81712917PCR2001, 2022-000946-14
- Status last verified
- Jan 2025
- First submitted
- 24 Mar 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study)
- ClinicalTrials.gov ID
- NCT05295927
- Acronym / sponsor ID
- CR109122
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative Decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 25 Mar 2022 (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.
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP) | Experimental | Drug: EPI-7386, Drug: Abiraterone Acetate, Drug: Prednisone or PrednisoloneParticipants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP. |
| Group B: EPI-3786 + Apalutamide | Experimental | Drug: EPI-7386, Drug: ApalutamideParticipants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed prostate adenocarcinoma
- Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
- Must be able to swallow oral medicines
- Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Key exclusion criteria (5 listed)
- Known central nervous system (CNS) metastases
- Non-metastatic castration-resistant prostate cancer (CRPC) (biochemical or locoregional disease only) is excluded from trial participation
- Evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s)
- Symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease
- Known disorder affecting gastrointestinal absorption
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 |
|---|---|---|
| EPI-7386EPI-7386 will be administered orally once daily. | Drug | Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP), Group B: EPI-3786 + Apalutamide |
| Abiraterone AcetateAbiraterone Acetate will be administered orally once daily. | Drug | Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP) |
| Prednisone or PrednisolonePrednisone or Prednisolone will be administered orally twice daily. | Drug | Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP) |
| ApalutamideApalutamide will be administered orally once daily. | Drug | Group B: EPI-3786 + Apalutamide |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 3 Years 3 Months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with AEs by Severity
Time frame: Up to 3 Years 3 Months
Number of participants with AEs by severity will be reported.
Number of Participants with Dose-limiting Toxicities (DLT)
Time frame: Up to 28 days of Cycle 1 (each cycle of 28 days)
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Composite Response Rate
Time frame: At 12 weeks
Composite response rate at 12 weeks, defined as either 90 percent (%) reduction in prostate-specific antigen (PSA) level from baseline (PSA-90), or objective response (confirmed per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in participants with measurable disease, or both at 12 weeks.
13 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Abiraterone
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and Abiraterone
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Abiraterone
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Abiraterone
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Abiraterone
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Abiraterone
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Apalutamide
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and apalutamide
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Apalutamide
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Apalutamide
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Apalutamide
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Apalutamide
Time frame: Day 1 of each cycle up to 3 cycles (each cycle of 28 days)
Serum Prostate-Specific Antigen (PSA)
Time frame: Up to 3 Years 3 Months
Results and safety
The study was stopped early (reason given: Administrative Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPI-7386, Abiraterone Acetate and Prednisone or Prednisolone in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 4 sites in 2 countries.
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 5 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: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 was stopped early (reason given: Administrative Decision). Results are not available in the source record.
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?
Number of Participants with Adverse Events (AEs) (time frame: Up to 3 Years 3 Months). 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 3 Feb 2025.