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NUV-1511

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment466
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06334432Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 466 — — Mar 14, 2024Oct 1, 2027Jan 14, 20268 United States
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06334432primaryCompletionDate: changed
LOWMay 24, 2026NCT06334432studyFirstPostDate: changed