Prostate CancerPhase 1/2NCT05191017
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
A Phase 1/2 study testing NUV-422 and Enzalutamide in people with Prostate Cancer and Prostatic Cancer, run by Nuvation Bio Inc. at 3 sites in United States.
Trial summary
NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Prostatic Cancer, Cancer of Prostate
- What is being tested?
- NUV-422 and Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2022to Jul 2026
- Phase
- Phase 1/2
- 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
- Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
- Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
- Have no known active or symptomatic central nervous system (CNS) disease
- Prior therapy with abiraterone required and:
- For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease
- For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors
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- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Adequate bone marrow and organ function
- Eligible to receive enzalutamide
- Life expectancy of > 6 months
Who cannot join
- History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide
- Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
- For Phase 1b only: Requires medications that are known to be moderate inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
- Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
- Known allergy or hypersensitivity to enzalutamide
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
NEXT Virginia
Fairfax, Virginia, 22031
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, 17325
About this study
Official title: Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
- Conditions
- Prostate Cancer, Prostatic Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate Neoplasm, Castrate Resistant Prostate Cancer
- Being tested
- NUV-422, Enzalutamide
- Keywords
- Phase 1, Phase 2, metastatic castration-resistant prostate cancer, NUV-422, enzalutamide, Xtandi, CDK, CDK inhibition, CDK2/4/6
- Medical subject headings
- Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUV-422Drug
NUV-422 is an investigational drug for oral dosing.
EnzalutamideDrug
Also called Xtandi
Enzalutamide
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined.
160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422. Receives: Drug: NUV-422; Drug: Enzalutamide |
| Phase 2 | Experimental | NUV-422 will be administered orally at the RP2cD in combination with enzalutamide.
160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422. Receives: Drug: NUV-422; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities
Measured: During the DLT period (28 days)
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)
PSA per standard criteria
Measured: Every 4 weeks throughout study treatment, an average of 6 months
Phase 2 Dose Expansion: Objective response rate (ORR)
ORR per standard criteria
Measured: Every 8 weeks throughout study treatment, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study startSep 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191017
- Sponsor's protocol ID
- NUV-422-04
- Status last verified
- Aug 2022
- First submitted
- 22 Dec 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT05191017
- Acronym / sponsor ID
- NUV-422-04
- Conditions
- Prostate Cancer, Prostatic Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate Neoplasm, Castrate Resistant Prostate Cancer
- Keywords
- Phase 1, Phase 2, metastatic castration-resistant prostate cancer, NUV-422, enzalutamide, Xtandi, CDK, CDK inhibition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Jan 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.
NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | Drug: NUV-422, Drug: EnzalutamideNUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422. |
| Phase 2 | Experimental | Drug: NUV-422, Drug: EnzalutamideNUV-422 will be administered orally at the RP2cD in combination with enzalutamide. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
- Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
- Have no known active or symptomatic central nervous system (CNS) disease
- Prior therapy with abiraterone required and:
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
Key exclusion criteria (7 listed)
- History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide
- Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
- Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
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 |
|---|---|---|
| NUV-422NUV-422 is an investigational drug for oral dosing. | Drug | Phase 1b Dose Escalation, Phase 2 |
| EnzalutamideAlso: XtandiEnzalutamide | Drug | Phase 1b Dose Escalation, Phase 2 |
Primary outcome
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Time frame: During the DLT period (28 days)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)
Time frame: Every 4 weeks throughout study treatment, an average of 6 months
PSA per standard criteria
Phase 2 Dose Expansion: Objective response rate (ORR)
Time frame: Every 8 weeks throughout study treatment, an average of 6 months
ORR per standard criteria
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NUV-422 and Enzalutamide in people with Prostate Cancer and Prostatic Cancer, run by Nuvation Bio Inc. at 3 sites in United States.
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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD) (time frame: During the DLT period (28 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 5 Aug 2022.