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NUC-7738

Phase 1

Advanced Cancer | Small molecule | Oncology |NuCana plc|Last Updated: Jan 12, 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 Enrollment135
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03829254A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and LymphomaPHASE1 RECRUITING 135 — — Jun 17, 2019Aug 1, 2026Jan 12, 20269 United Kingdom
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Study Endpoints
Primary Endpoints
Number of patients with dose-limiting toxicities
From the date of consent until 30 days after the last dose of NUC-7738 administered

Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours

Number of patients with treatment-emergent adverse events (CTCAE v5.0)
From the date of consent until 30 days after the last dose of NUC-7738 administered

Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours

Number of patients with clinically significant laboratory changes (CTCAE v5.0)
From the date of consent until 30 days after the last dose of NUC-7738 administered

Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours

Number of patients with changes in physical exam, vital signs, and serial electrocardiograms.
From the date of consent until 30 days after the last dose of NUC-7738 administered

Phase I: Safety and tolerability of NUC-7738 in patients with advanced solid tumours

MTD for NUC-7738 administered via weekly and fortnightly dosing schedules in patients with advanced solid tumours
Until completion of Phase I (an average of 1 year)

Phase I

Percentage change from baseline in tumour size
Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)

Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007)

Objective response rate (ORR)
Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)

Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the number of patients achieving a confirmed response (complete response \[CR\] or partial response \[PR\])

Duration of response (DoR)
Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)

Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the time from the time measurement criteria are first met for CR or PR until the first date that recurrence or progressive disease (PD) is objectively documented (responders only)

Disease control rate (DCR)
Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)

Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the proportion of patients achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response

Duration of stable disease (DoSD)
Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)

Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the time from the time measurement criteria are first met for SD until the first date that recurrence or PD is objectively documented

Progression free survival (PFS)
Assessed every 8 weeks following Day 1 up to and including Cycle 12 (each cycle is 14 days) in single-agent cohorts and Cycle 8 in combination cohorts (each cycle is 21 days), moving to every 12 weeks until the end of study (up to 22 months)

Phase II: Efficacy (per RECIST v 1.1, iRECIST or Cheson et al, 2007): defined as the time from first dose of study treatment until the date of objective disease progression or death

Secondary Endpoints
Phase I: Plasma concentration of NUC-7738 at end of infusion (Cinf)
Samples collected on Days 1, 2, and 3 of Cycle 1 and Days 1 and 2 of Cycle 2 (cycle: 14 days).
Phase I: Maximum observed plasma concentration (Cmax) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738
Samples collected on Days 1, 2, and 3 of Cycle 1 and Days 1 and 2 of Cycle 2 (cycle: 14 days).
Phase I: Area under the plasma concentration-time curve (AUC) of NUC-7738, 3'-dA, 3'-deoxyinosine (3'-dI) and alanine phosphate metabolite of NUC-7738
Samples collected on Days 1, 2, and 3 of Cycle 1 and Days 1 and 2 of Cycle 2 (cycle: 14 days).
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NUC-7738EXPERIMENTALNUC-7738 administered by intravenous infusion on a weekly or fortnightly schedule. In the weekly dosing schedule, NUC-7738 is administered on Days 1 and 8 of a 14-day cycle. In the fortnightly dosing schedule, NUC-7738 is administered on Day 1 of a 14-day cycle.
NUC-7738 + pembrolizumabEXPERIMENTALNUC-7738 administered by intravenous infusion on a weekly schedule on Days 1, 8 and 15 of a 21-day cycle. Pembrolizumab administered by intravenous infusion every 3 weeks on Day 1 of a 21-day cycle.
Interventions
NameTypeDescription
NUC-7738DRUGNUC-7738
PembrolizumabDRUGPembrolizumab
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Provision of signed written informed consent. 2. Solid tumour cohorts only (Phase I and Phase II; excluding NUC-7738 + pembrolizumab cohort): Histologically confirmed diagnosis of an advanced solid tumour with measurable disease as per RECIST v1.1 criteria and/or evaluable di...

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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03829254primaryCompletionDate: changed
LOWMay 24, 2026NCT03829254studyFirstPostDate: changed