Metastatic Castration-resistant Prostate CancerPhase 1/2NCT04556617
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1/2 study testing PLX2853 20 mg, Olaparib and Abiraterone acetate in people with Metastatic Castration-resistant Prostate Cancer, run by Opna Bio LLC at 8 sites in 2 countries.
Trial summary
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- PLX2853 20 mg, Olaparib and Abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 21 Sep 2020to 24 May 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ≥18 years at the time of signing informed consent.
- Histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses.
- Eastern Cooperative Oncology Group Performance Status 0 to 1.
- Adequate organ function as demonstrated following laboratory values.
- Fertile male subjects with female sexual partners must agree to use a highly effective method of birth control during the study and for 90 days after the last dose of study drug.
- Except as specified above for organ function, all drug-related toxicity from previous cancer therapy (including ongoing Abiraterone Acetate + Prednisone therapy if applicable) must be resolved (to Grade ≤1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) prior to study treatment administration (Grade 2: alopecia, hot flashes, decreased libido, or neuropathy is allowed).
- Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
Who cannot join
- Prior exposure to a bromodomain inhibitor.
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- Clinically significant cardiac disease.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption.
- Active known second malignancy with the exception of any of the following:
- Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin.
Show all 11Show fewer
- Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years.
- Any other cancer from which the subject has been disease-free for ≥3 years.
- Subject is participating in any other therapeutic clinical study (observational or registry studies are allowed).
- Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgment of the Investigator.
- Receipt of any anti-cancer therapy prior to Cycle 1 Day 1 with less than protocol defined wash-out with the exception of Abiraterone Acetate (for subjects enrolling into Abiraterone Acetate Combination) and GnRH therapy.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Chicago
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialist
Fairfax, Virginia, 22031
University of Wisconsin
Madison, Wisconsin, 53792
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Tennessee Oncology/ Sarah Cannon
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Being tested
- PLX2853 20 mg, Olaparib, Abiraterone acetate, Prednisone, PLX2853 40 mg
- Keywords
- PLX2853, Metastatic Castration-resistant Prostate Cancer, Olaparib, Abiraterone Acetate, Adenocarcinoma, Prostate Cancer
- Medical subject headings
- Adenocarcinoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX2853 20 mgDrug
PLX2853 tablets
OlaparibDrug
Olaparib tablets
Abiraterone acetateDrug
Abiraterone acetate tablets
PrednisoneDrug
Prednisone (or equivalent) tablets
PLX2853 40 mgDrug
PLX2853 tablets
PLX2853 80 mgDrug
PLX2853 tablets
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b PLX2853 (20 mg) + Olaparib | Experimental | Phase 1b dose escalation Receives: Drug: PLX2853 20 mg; Drug: Olaparib |
| Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone | Experimental | Phase 1b dose escalation Receives: Drug: Abiraterone acetate; Drug: Prednisone; Drug: PLX2853 40 mg |
| Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone | Experimental | Phase 1b dose escalation Receives: Drug: Abiraterone acetate; Drug: Prednisone; Drug: PLX2853 80 mg |
| Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone | Experimental | Phase 2a dose expansion Receives: Drug: Abiraterone acetate; Drug: Prednisone; Drug: PLX2853 80 mg |
| Phase 1b PLX2853 (40 mg) + Olaparib | Experimental | Phase 1b dose escalation Receives: Drug: Olaparib; Drug: PLX2853 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities
Dose limiting toxicity defined as clinically significant adverse events or laboratory abnormalities occurring during first cycle of study drug administration that are possibly related to study drug and that meet specific criteria defined in the protocol
Measured: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
Phase 1b (Both Arms): Incidence of TEAEs That Are Related to Treatment
Treatment-emergent adverse events are those reported after study drug has been administered.
Measured: From time of first dose of PLX2853 and combination agent(s) until 30 days from end of treatment (an average of 103 days)
Determination of Maximum Tolerated Dose
To be evaluated in both PLX2853 + AA + pred and PLX2853 + olap group; If DLTs observed in 2 or more subjects the dose will be considered intolerable and MTD will have been reached.
Measured: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start21 Sep 2020
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: study terminated due to business realignment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opna Bio LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556617
- Sponsor's protocol ID
- PLX124-04
- Status last verified
- Apr 2025
- First submitted
- 14 Sep 2020
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT04556617
- Acronym / sponsor ID
- PLX124-04
- Keywords
- PLX2853, Metastatic Castration-resistant Prostate Cancer, Olaparib, Abiraterone Acetate, Adenocarcinoma, Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to business realignment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Opna Bio LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 8 Apr 2025
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 research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1b PLX2853 (20 mg) + Olaparib | Experimental | Drug: PLX2853 20 mg, Drug: OlaparibPhase 1b dose escalation |
| Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone | Experimental | Drug: Abiraterone acetate, Drug: Prednisone, Drug: PLX2853 40 mgPhase 1b dose escalation |
| Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone | Experimental | Drug: Abiraterone acetate, Drug: Prednisone, Drug: PLX2853 80 mgPhase 1b dose escalation |
| Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone | Experimental | Drug: Abiraterone acetate, Drug: Prednisone, Drug: PLX2853 80 mgPhase 2a dose expansion |
| Phase 1b PLX2853 (40 mg) + Olaparib | Experimental | Drug: Olaparib, Drug: PLX2853 40 mgPhase 1b dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years at the time of signing informed consent.
- Histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses.
- Eastern Cooperative Oncology Group Performance Status 0 to 1.
- Adequate organ function as demonstrated following laboratory values.
- Fertile male subjects with female sexual partners must agree to use a highly effective method of birth control during the study and for 90 days after the last dose of study drug.
Key exclusion criteria (11 listed)
- Prior exposure to a bromodomain inhibitor.
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- Clinically significant cardiac disease.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption.
- Active known second malignancy with the exception of any of the following:
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 |
|---|---|---|
| PLX2853 20 mgPLX2853 tablets | Drug | Phase 1b PLX2853 (20 mg) + Olaparib |
| OlaparibOlaparib tablets | Drug | Phase 1b PLX2853 (20 mg) + Olaparib, Phase 1b PLX2853 (40 mg) + Olaparib |
| Abiraterone acetateAbiraterone acetate tablets | Drug | Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone, Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone, Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone |
| PrednisonePrednisone (or equivalent) tablets | Drug | Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone, Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone, Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone |
| PLX2853 40 mgPLX2853 tablets | Drug | Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone, Phase 1b PLX2853 (40 mg) + Olaparib |
| PLX2853 80 mgPLX2853 tablets | Drug | Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone, Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone |
Primary outcome
Number of Participants With Dose-Limiting Toxicities
Time frame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
Dose limiting toxicity defined as clinically significant adverse events or laboratory abnormalities occurring during first cycle of study drug administration that are possibly related to study drug and that meet specific criteria defined in the protocol
Phase 1b (Both Arms): Incidence of TEAEs That Are Related to Treatment
Time frame: From time of first dose of PLX2853 and combination agent(s) until 30 days from end of treatment (an average of 103 days)
Treatment-emergent adverse events are those reported after study drug has been administered.
Determination of Maximum Tolerated Dose
Time frame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
To be evaluated in both PLX2853 + AA + pred and PLX2853 + olap group; If DLTs observed in 2 or more subjects the dose will be considered intolerable and MTD will have been reached.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metastatic Castration-resistant Prostate Cancer
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PLX2853 20 mg, Olaparib and Abiraterone acetate in people with Metastatic Castration-resistant Prostate Cancer, run by Opna Bio LLC at 8 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 7 inclusion and 11 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Dose-Limiting Toxicities (time frame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)). The study lists 3 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 8 Apr 2025.