Advanced Breast CancerPhase 1/2NCT05191004
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
A Phase 1/2 study testing NUV-422 and Fulvestrant in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Nuvation Bio Inc. at 5 sites in United States.
Trial summary
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer
- What is being tested?
- NUV-422 and Fulvestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2022to Sep 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
- Men and women with diagnosis of locally advanced inoperable or metastatic HR+HER2- breast cancer
- Evidence of disease progression on immediate prior therapy as determined by the Investigator per standard criteria
- Patients must have received standard of care treatments for their breast cancer and be eligible to receive fulvestrant
- Prior standard of care treatments must include treatment with hormonal therapy in combination with an approved CDK4/6 inhibitor
- Patients must have endocrine-resistant disease
- Have no known active or symptomatic central nervous system (CNS) disease
Show all 10Show fewer
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
- Life expectancy of > 6 months
- Eligible to receive fulvestrant
- Adequate bone marrow and organ function
Who cannot join
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422 and fulvestrant
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (of < 5 half-lives) for myelosuppressive agent prior to first dose of NUV-422 and fulvestrant
- Moderate liver impairment which would require a reduced dose of fulvestrant
- Requires medications that are known to be strong inducers and/or inhibitors of CYP3A4/5 enzymes
- For Phase 1b only: requires medications that are known to be moderate inducers and/or inhibitors of CYP3A4/5 enzymes
- Known allergy or hypersensitivity to fulvestrant
- For Phase 2 only: prior therapy with fulvestrant and/or investigational ER targeted agent
- Females who are pregnant or breast feeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801
Gabrail Cancer Center Research
Canton, Ohio, 44718
NEXT Virginia
Fairfax, Virginia, 22031
Compassionate Cancer Care Research Inc.
Fountain Valley, California, 92708
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, 17325
About this study
Official title: Randomized, Non-Comparative Phase 1/2 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (HR+HER2-) Advanced Breast Cancer (aBC)
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma, Cancer of the Breast, Cancer of Breast
- Being tested
- NUV-422, Fulvestrant
- Keywords
- Phase 1, Phase 2, metastatic breast cancer, advanced breast cancer, hormone receptor positive, HR+, human epidermal growth factor receptor 2 negative, HER2-, HR+ HER2-, estrogen receptor positive, ER+, NUV-422, fulvestrant, CDK, CDK inhibition, CDK2/4/6
- Medical subject headings
- Breast Neoplasms
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.
FulvestrantDrug
Also called Faslodex
Fulvestrant
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | NUV-422 will be administered orally at escalating dose levels in combination with fulvestrant until the recommended Phase 2 combination dose (RP2cD) is determined.
500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Receives: Drug: NUV-422; Drug: Fulvestrant |
| Phase 2 NUV-422 + fulvestrant | Experimental | NUV-422 will be administered orally at the RP2cD in combination with fulvestrant.
500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Receives: Drug: NUV-422; Drug: Fulvestrant |
| Phase 2 NUV-422 monotherapy | Experimental | NUV-422 will be administered orally at the RP2cD. Receives: Drug: NUV-422 |
| Phase 2 fulvestrant monotherapy | Experimental | 500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Receives: Drug: Fulvestrant |
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 fulvestrant 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: Objective Response Rate (ORR)
ORR per standard criteria
Measured: Every 8 weeks through 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 completionJun 2025 (estimated)
- Study completionSep 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 Advanced Breast 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
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential assignment or parallel assignment will be applied (in both Phase 1 and Phase 2), depending on the stage of the study at the time of a patient's enrollment.
- 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
- NCT05191004
- Sponsor's protocol ID
- NUV-422-03
- Status last verified
- Jul 2023
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jul 2023
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Non-Comparative Phase 1/2 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (HR+HER2-) Advanced Breast Cancer (aBC)
- ClinicalTrials.gov ID
- NCT05191004
- Acronym / sponsor ID
- NUV-422-03
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma, Cancer of the Breast, Cancer of Breast
- Keywords
- Phase 1, Phase 2, metastatic breast cancer, advanced breast cancer, hormone receptor positive, HR+, human epidermal growth factor receptor 2 negative, HER2-
- 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
- Jun 2025 (estimated)
- Study completion
- Sep 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-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Sequential assignment or parallel assignment will be applied (in both Phase 1 and Phase 2), depending on the stage of the study at the time of a patient's enrollment.
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | Drug: NUV-422, Drug: FulvestrantNUV-422 will be administered orally at escalating dose levels in combination with fulvestrant until the recommended Phase 2 combination dose (RP2cD) is determined. 500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. |
| Phase 2 NUV-422 + fulvestrant | Experimental | Drug: NUV-422, Drug: FulvestrantNUV-422 will be administered orally at the RP2cD in combination with fulvestrant. 500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. |
| Phase 2 NUV-422 monotherapy | Experimental | Drug: NUV-422NUV-422 will be administered orally at the RP2cD. |
| Phase 2 fulvestrant monotherapy | Experimental | Drug: Fulvestrant500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women with diagnosis of locally advanced inoperable or metastatic HR+HER2- breast cancer
- Evidence of disease progression on immediate prior therapy as determined by the Investigator per standard criteria
- Patients must have received standard of care treatments for their breast cancer and be eligible to receive fulvestrant
- Patients must have endocrine-resistant disease
- Have no known active or symptomatic central nervous system (CNS) disease
Key exclusion criteria (8 listed)
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422 and fulvestrant
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (of < 5 half-lives) for myelosuppressive agent prior to first dose of NUV-422 and fulvestrant
- Moderate liver impairment which would require a reduced dose of fulvestrant
- Requires medications that are known to be strong inducers and/or inhibitors of CYP3A4/5 enzymes
- Known allergy or hypersensitivity to fulvestrant
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 NUV-422 + fulvestrant, Phase 2 NUV-422 monotherapy |
| FulvestrantAlso: FaslodexFulvestrant | Drug | Phase 1b Dose Escalation, Phase 2 NUV-422 + fulvestrant, Phase 2 fulvestrant monotherapy |
Primary outcome
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with fulvestrant 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: Objective Response Rate (ORR)
Time frame: Every 8 weeks through 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 11 Jul 2023.
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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.
5 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 Fulvestrant in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Nuvation Bio Inc. at 5 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 8 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 fulvestrant to determine the recommended Phase 2 combination dose (RP2cD) (time frame: During the DLT period (28 days)). The study lists 2 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 11 Jul 2023.