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NUV-1511

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Nuvation Bio Inc.|Last Updated: Jan 14, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment466

FDA Designations

No designations recorded

Clinical trial landscape

NUV-1511 · 1 trial · 5 indications

Phase 1 1
NCT06334432Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid TumorsAdvanced Solid Tumor
ACTIVE NOT_RECRUITING466 Analytics
PHASE1ACTIVE NOT_RECRUITING
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
Advanced Solid Tumor
NCT06334432466
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Study Endpoints

Primary Endpoints

Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors
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))
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)
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
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
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)

Secondary Endpoints

Phase 1: Explore preliminary efficacy of NUV-1511
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
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
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1: Schedule AOTHERSchedule A evaluating escalating dose levels of NUV-1511
Phase 1: Schedule BOTHERSchedule B evaluating escalating dose levels of NUV-1511
Phase 2: Tumor Type 1EXPERIMENTALTumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.
Phase 2: Tumor Type 2EXPERIMENTALTumor 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 comersEXPERIMENTALAll tumor types allowed per protocol. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1.

Interventions

NameTypeDescription
NUV-1511DRUGNovel small molecule
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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: * HER2- metastatic breast cancer: 1. Hormone refractory hormone receptor positive metastatic breast cancer with progression on or a...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about NUV-1511

What is NUV-1511 used for?

NUV-1511 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is being studied in adult patients with advanced solid tumors, including HER2-negative breast cancer, metastatic castration-resistant prostate cancer, pancreatic cancer, and platinum-resistant ovarian cancer.

Who is developing NUV-1511?

NUV-1511 is being developed by Nuvation Bio Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol NUVB.

What phase is NUV-1511 in?

NUV-1511 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 1 clinical trial for advanced solid tumors.

What clinical trials is NUV-1511 in?

NUV-1511 is being studied in a Phase 1 clinical trial with the identifier NCT06334432. This trial is titled 'Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors' and is active but not recruiting participants. The trial is being conducted in the United States.

What is the enrollment size of the NUV-1511 clinical trial?

The Phase 1 clinical trial of NUV-1511 (NCT06334432) has a planned enrollment of 466 participants. The trial includes adult patients aged 18 years and older with advanced solid tumors, including HER2-negative breast cancer, metastatic castration-resistant prostate cancer, pancreatic cancer, and platinum-resistant ovarian cancer.