Advanced Solid TumorPhase 1/2NCT06334432
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
A Phase 1/2 study testing NUV-1511 in people with Advanced Solid Tumor and HER2-negative Breast Cancer, run by Nuvation Bio Inc. at 8 sites in United States.
Trial summary
NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, HER2-negative Breast Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- NUV-1511
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Mar 2024to Oct 2027
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohort(s): must meet one of the following criteria:
- HER2- metastatic breast cancer:
- Hormone refractory hormone receptor positive metastatic breast cancer with progression on or after treatment with CDK4/6 inhibitor plus at least one line of systemic chemotherapy in the advanced setting
- Triple negative metastatic breast cancer with progression after at one line of systemic chemotherapy in the advanced setting.
- Patients with advanced solid tumors that progressed on or following treatment with Enhertu and/or Trodelvy per label
- mCRPC: Histologically confirmed, metastatic castration resistant adenocarcinoma of the prostate
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- May have received up to 2 prior chemotherapies in mCRPC setting
- Prior therapy with PARP (poly-ADP ribose polymerase) inhibitor, PLUVICTO, Radium-223, or Provenge is allowed
- Pancreatic cancer: PDAC (pancreatic ductal adenocarcinoma) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting.
- PROC: Histologically or cytologically confirmed platinum-resistant high-grade serous ovarian, fallopian, or primary peritoneal cancer;
- Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohorts (except mCRPC; see inclusion criterion 2 above): must have measurable disease per RECIST 1.1
- Phase 2 All Comers cohort: Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for whom there is no standard effective therapy available.
- Adequate bone marrow and organ function.
- Provide informed consent, which includes compliance with protocol-specified requirements and restrictions
Who cannot join
- Chemotherapy, hormonal therapy (with the exception of ongoing luteinizing hormone-releasing hormone analogs in male patients and premenopausal females), radiation therapy, or biological anticancer therapy within 14 days before the first dose of study treatment
- Treatment with an investigational agent for any indication within 14 days before the first dose of study treatment for non-myelosuppressive agent, or within 21 days or <5 half-lives before the first dose of study treatment, whichever is longer, for a myelosuppressive agent
- Ongoing or active infection requiring systemic therapy, or an infection requiring hospitalization or intravenous therapy within 2 weeks before the first dose of study treatment
- Resting left ventricular ejection fraction (LVEF) of <50% obtained by echocardiography or multigated acquisition scan (MUGA)
- History of significant cardiac disease, including myocardial infarction, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation), syncope of cardiovascular etiology, or cardiac arrest:
- Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infections not currently controlled by current disease-specific therapy. The following exceptions apply:
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- Major surgical procedure within 2 weeks before the first dose of study treatment, or an anticipated need for major surgery during the course of the study
- Other cancer within 2 years before the first dose of study treatment with metastatic or local recurrence potential that could negatively impact survival and/or potentially confound tumor response assessments. Patients with a history of other cancers in the past 2 years should be discussed with the Medical Monitor.
- Female patients who are pregnant or breastfeeding
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Karmanos Cancer Center
Detroit, Michigan, 48201
NEXT Oncology
Fairfax, Virginia, 22031
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
NEXT Oncology
Irving, Texas, 75038
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
START Mountain
Salt Lake City, Utah, 84124
Fred Hutchinson
Seattle, Washington, 98109
About this study
Official title: A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HER2-negative Breast Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC), Pancreatic Cancer, Platinum-resistant Ovarian Cancer (PROC)
- Being tested
- NUV-1511
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUV-1511Drug
Novel small molecule
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Schedule A | Other | Schedule A evaluating escalating dose levels of NUV-1511 Receives: Drug: NUV-1511 |
| Phase 1: Schedule B | Other | Schedule B evaluating escalating dose levels of NUV-1511 Receives: Drug: NUV-1511 |
| Phase 2: Tumor Type 1 | Experimental | Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated. Receives: Drug: NUV-1511 |
| Phase 2: Tumor Type 2 | Experimental | Tumor type to be selected after Phase 1. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1. Receives: Drug: NUV-1511 |
| Phase 2: All comers | Experimental | All tumor types allowed per protocol. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1. Receives: Drug: NUV-1511 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors
Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities
Measured: First 28 days of dosing (DLT evaluation period)
Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))
Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities
Measured: First 28 days of dosing (DLT evaluation period)
Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI
Measured: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Measured: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Confirm the optimal NUV-1511 target tumor types for further development
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Measured: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Secondary outcomes (15)
Phase 1: Explore preliminary efficacy of NUV-1511
Overall response rate and duration of response per RECIST 1.1. Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.
Measured: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Overall response rate and duration of response per composite response rate (for mCRPC). Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.
Measured: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Overall response rate and duration of response per response rates in specific disease markers. Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.
Measured: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Characterize the PK profile of NUV-1511
Parameters include, but not limited to, maximum observed plasma concentration (Cmax)
Measured: Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.
Characterize the PK profile of NUV-1511
Parameters include, but not limited to, area under the plasma concentration-time curve (AUC)
Measured: Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Incidence of TEAEs and SAEs
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Laboratory abnormalities
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Duration of response
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Clinical best response
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Progression free survival
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Overall survival
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
PK exposure-response modeling, which includes measuring plasma concentration versus overall response rate
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
PK exposure-response modeling, which includes measuring plasma concentration versus progression free survival
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
PK exposure-response modeling, which includes measuring plasma concentration versus treatment emergent adverse events and serious adverse events.
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Response rates in disease-specific markers
Measured: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start14 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334432
- Sponsor's protocol ID
- NUV-1511-01
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06334432
- Acronym / sponsor ID
- NUV-1511-01
- Conditions
- Advanced Solid Tumor, HER2-negative Breast Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC), Pancreatic Cancer, Platinum-resistant Ovarian Cancer (PROC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Mar 2024 (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-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Schedule A | Other | Drug: NUV-1511Schedule A evaluating escalating dose levels of NUV-1511 |
| Phase 1: Schedule B | Other | Drug: NUV-1511Schedule B evaluating escalating dose levels of NUV-1511 |
| Phase 2: Tumor Type 1 | Experimental | Drug: NUV-1511Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated. |
| Phase 2: Tumor Type 2 | Experimental | Drug: NUV-1511Tumor type to be selected after Phase 1. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1. |
| Phase 2: All comers | Experimental | Drug: NUV-1511All tumor types allowed per protocol. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohort(s): must meet one of the following criteria:
- HER2- metastatic breast cancer:
- Patients with advanced solid tumors that progressed on or following treatment with Enhertu and/or Trodelvy per label
- mCRPC: Histologically confirmed, metastatic castration resistant adenocarcinoma of the prostate
- Pancreatic cancer: PDAC (pancreatic ductal adenocarcinoma) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting.
Key exclusion criteria (9 listed)
- Chemotherapy, hormonal therapy (with the exception of ongoing luteinizing hormone-releasing hormone analogs in male patients and premenopausal females), radiation therapy, or biological anticancer therapy within 14 days before the first dose of study treatment
- Treatment with an investigational agent for any indication within 14 days before the first dose of study treatment for non-myelosuppressive agent, or within 21 days or <5 half-lives before the first dose of study treatment, whichever is longer, for a myelosuppressive agent
- Ongoing or active infection requiring systemic therapy, or an infection requiring hospitalization or intravenous therapy within 2 weeks before the first dose of study treatment
- Resting left ventricular ejection fraction (LVEF) of <50% obtained by echocardiography or multigated acquisition scan (MUGA)
- History of significant cardiac disease, including myocardial infarction, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation), syncope of cardiovascular etiology, or cardiac arrest:
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-1511Novel small molecule | Drug | Phase 1: Schedule A, Phase 1: Schedule B, Phase 2: All comers, Phase 2: Tumor Type 1, Phase 2: Tumor Type 2 |
Primary outcome
Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors
Time frame: First 28 days of dosing (DLT evaluation period)
Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities
Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))
Time frame: First 28 days of dosing (DLT evaluation period)
Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities
Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI
Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development
Time frame: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Phase 2: Confirm the optimal NUV-1511 target tumor types for further development
Time frame: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
15 secondary outcomes
Phase 1: Explore preliminary efficacy of NUV-1511
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Characterize the PK profile of NUV-1511
Time frame: Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.
Characterize the PK profile of NUV-1511
Time frame: Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
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 14 Jan 2026.
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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.
8 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-1511 in people with Advanced Solid Tumor and HER2-negative Breast Cancer, run by Nuvation Bio Inc. at 8 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 14 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. 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. 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?
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?
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 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors (time frame: First 28 days of dosing (DLT evaluation period)). The study lists 5 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 14 Jan 2026.