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NUC-1031

Phase 1

Cancer | Small molecule | Oncology |NuCana plc|Last Updated: Mar 20, 2024

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01621854NUC-1031 in Patients With Advanced Solid TumoursPHASE1 COMPLETED 68 — — Oct 1, 2012Jun 1, 2015Mar 20, 20241 United Kingdom
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Study Endpoints
Primary Endpoints
To determine the RP2D of NUC-1031 administered as either an I.V. weekly or twice-weekly schedule in patients with advanced solid tumours.
1.5 years

Adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments will be assessed

To further evaluate the safety profile of NUC-1031 in an expanded cohort at RP2D
1 year

Adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments

Secondary Endpoints
To determine the pharmacokinetics of NUC-1031 and its metabolites.
1.5 years
To explore the preliminary anti-tumour activity of NUC-1031 [given at the RP2D and preferred schedule selected from Part I]
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NUC-1031EXPERIMENTALCohort 1, Schedule A, NUC-1031 I.V. 1000mg/m2, Days 1, 8, \& 15 every 28 days Cohort 1, Schedule B, NUC-1031 I.V. 500mg/m2, Days 1 \& 5, 8 \& 12, 15 \&19 every 28 days Cohort 2, Schedule A, NUC-1031 I.V. 2000mg/m2, Days 1, 8, \& 15 every 28 days Cohort 2, Schedule B, NUC-1031 I.V. 1000mg/m2, Days 1 \& 5, 8 \& 12, 15 \&19 every 28 days
Interventions
NameTypeDescription
NUC-1031DRUGCohort 1, Schedule A, NUC-1031 I.V. 1000mg/m2, Days 1, 8, \& 15 every 28 days Cohort 1, Schedule B, NUC-1031 I.V. 500mg/m2, Days 1 \& 5, 8 \& 12, 15 \&19 every 28 days Cohort 2, Schedule A, NUC-1031 I.V. 2000mg/m2, Days 1, 8, \& 15 every 28 days Cohort 2, Schedule B, NUC-1031 I.V. 1000mg/m2, Days 1 \& 5, 8 \& 12, 15 \&19 every 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Provision of signed written informed consent. 2. Diagnosis: Histologically or cytologically confirmed diagnosis of cancer which is not amenable to standard therapy, is refractory to standard therapy or for which no standard therapy exists. 3. Age ≥ 18 years. 4. Eastern Cooper...

Countries:United Kingdom
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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