ClinicalTrials.gg
Active, not recruitingNCT06334432Updated Jan 14, 2026

Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

A Phase 1/2 interventional study of NUV-1511 in Advanced Solid Tumor, HER2-negative Breast Cancer and Metastatic Castration-resistant Prostate Cancer (mCRPC), sponsored by Nuvation Bio Inc.. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by Nuvation Bio Inc. · Phase 1/2, Interventional, and Treatment

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Phase
Phase 1/2
Study type
Interventional
Enrollment
466
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,852 studies in Pancreatic Neoplasms with a site in United States — 302 open to participants now, 474 under way, 25 of them phase 3. Pancreatic Neoplasms · United States.

Planned enrollment
73rd of 1,575
466 · median 37
Started
2024
with 67 others
Phase 1/2
223 of 1,852
44 open now
Primary completion
2027-03
later than 184 of 473 live
Registered
1,655th of 1,852
by date

Among the 1,852 studies in Pancreatic Neoplasms with a site in United States, this one is the 73rd largest by planned enrollment of the 1,575 interventional ones that give a count, is one of 68 that started in 2024, is one of 223 in phase 1/2, reaches primary completion later than 184 of the 473 other live ones, and was the 1,655th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,006 are open to participants now.

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Open to participants now

302 of the 1,852 studies in Pancreatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:

297 more — sign in →

All 302 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.

03

Conditions studied

  • Advanced Solid Tumor
  • HER2-negative Breast Cancer
  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Pancreatic Cancer
  • Platinum-resistant Ovarian Cancer (PROC)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohort(s): must meet one of the following criteria:
  • - breast cancer:

    1. Hormone hormone receptor positive metastatic breast cancer with progression on or after treatment with CDK4/6 inhibitor plus at least one in the advanced setting
    2. 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: confirmed, metastatic castration resistant adenocarcinoma of the prostate

    1. May have received up to 2 prior chemotherapies in mCRPC setting
    2. 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 per 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 , which includes compliance with protocol-specified requirements and restrictions

Exclusion criteria

Exclusion Criteria:

  • 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 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 (LVEF) of \<50% obtained by echocardiography or multigated acquisition scan (MUGA)
  • History of significant cardiac disease, including myocardial infarction, Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation), syncope of cardiovascular etiology, or cardiac arrest:
  • Known disease or active systemic disease such as systemic lupus erythematosus, (HIV), virus (HBV), or virus (HCV) infections not currently controlled by current disease-specific therapy. The following exceptions apply:
  • 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 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
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
466 participants (estimated)

Study arms

  • Other
    Phase 1: Schedule A

    Schedule A evaluating escalating dose levels of NUV-1511

    Drug: NUV-1511

  • Other
    Phase 1: Schedule B

    Schedule B evaluating escalating dose levels of NUV-1511

    Drug: NUV-1511

  • Experimental
    Phase 2: Tumor Type 1

    Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.

    Drug: NUV-1511

  • Experimental
    Phase 2: Tumor Type 2

    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.

    Drug: NUV-1511

  • Experimental
    Phase 2: All comers

    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.

    Drug: NUV-1511

Interventions

  • DrugNUV-1511

    Novel small molecule

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: First 28 days of dosing (DLT evaluation period)

  2. 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

    Time frame: First 28 days of dosing (DLT evaluation period)

  3. 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

    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

  4. 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)

    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

  5. 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)

    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

Secondary outcomes

  1. 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.

    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

  2. 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.

    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

  3. 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.

    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

  4. Characterize the PK profile of NUV-1511

    Parameters include, but not limited to, maximum observed plasma concentration (Cmax)

    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.

  5. Characterize the PK profile of NUV-1511

    Parameters include, but not limited to, area under the plasma concentration-time curve (AUC)

    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.

  6. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Incidence of TEAEs and SAEs

    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

  7. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Laboratory abnormalities

    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

  8. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Duration of response

    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

  9. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Clinical best response

    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

  10. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Progression free survival

    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

  11. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Overall survival

    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

  12. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    PK exposure-response modeling, which includes measuring plasma concentration versus overall response rate

    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

  13. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    PK exposure-response modeling, which includes measuring plasma concentration versus progression free survival

    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

  14. 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.

    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

  15. Phase 2: Further evaluate the safety and efficacy of NUV-1511

    Response rates in disease-specific markers

    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

Other outcomes

  1. Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis

    Blood sample for exploratory analysis of circulating DNA

    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

  2. Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis

    Blood sample for exploratory analysis of gene expression (including that of hormone receptors and efflux transporters)

    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

  3. Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity

    Tumor biopsy for exploratory analysis of tumor genome

    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

  4. Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity

    Tumor biopsy for exploratory analysis of epigenome

    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

  5. Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity

    Tumor biopsy for exploratory analysis of gene expression

    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

  6. Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity

    Identification of genetic factors that predict toxicity

    Time frame: Blood and tumor biopsy collection at the time of enrollment

  7. Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity

    Identification of genetic factors that predict anti-tumor activity

    Time frame: Blood and tumor biopsy collection at the time of enrollment

  8. Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity

    Identification of genetic factors that predict metabolism of NUV-1511

    Time frame: Blood and tumor biopsy collection at the time of enrollment

  9. Evaluate drug exposure-response relationship

    PK exposure response modeling which includes measuring PK exposure versus efficacy

    Time frame: Periodic PK sample collection through disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

  10. Evaluate drug exposure-response relationship

    PK exposure response modeling which includes measuring PK exposure versus safety

    Time frame: Periodic PK sample collection through disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

07

Study locations

8 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.

Of 115 industry-sponsored phase 1/2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 88. This study's planned 36 months is below that.

Counting every sponsor, half of 209 studies reached it within 51 months; a quarter within 36 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2024
First posted
Mar 28, 2024
StartActual
Mar 14, 2024
Primary completionEst.
Mar 2027
CompletionEst.
Oct 2027
Last update
Jan 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06334432
Lead sponsor
Nuvation Bio Inc.
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Mar 14, 2024
Primary completion
Mar 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jan 14, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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