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AZD6738

Phase 1

Neoplasm | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 1, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06754761Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of CeralasertibPHASE1 NOT YET_RECRUITING 8 — — Jan 17, 2025Aug 8, 2025Jan 1, 20252 United Kingdom
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Study Endpoints
Primary Endpoints
To evaluate absolute bioavailability Ceralasertib and PK of Ceralasertib and [14C]-Ceralasertib after administration of oral dose of Ceralasertib and IV [14C]-Ceralasertib (Part A
Through end of Part A, approximately 5 weeks including screening period

Absolute bioavailability (F) of Ceralasertib and PK parameters

To determine the rates and major excretory routes of Ceralasertib and its metabolites after IV dose of [14C]-Ceralasertib (Part A) and a oral dose of [14C]-Ceralasertib (Part B)
Through end of Part B, approximately 10 weeks including screening period

\[14C\]-Ceralasertib (Part A) or total radioactivity (Part B) recovery in urine and faeces

To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Through end of the part B, approximately 10 weeks (Including screening period)

AUCinf

Secondary Endpoints
To provide biologic samples for metabolic profiling and identification after oral dose of [14C]-Ceralasertib (Part B)
Through end of the part B, approximately 10 weeks (Including screening period)
To assess the safety of Ceralasertib in participants with NSCLC, ovarian cancer, or endometrial cancer (Parts A and B)
Through study completion, approximately 9 - 11 weeks, with screening included
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Primary Treatment Arm - AZD6738EXPERIMENTALPart A - oral dose of Ceralasertib and a radiolabelled IV microdose of \[14C\]-Ceralasertib Part B - oral dose of \[14C\]-Ceralasertib
Interventions
NameTypeDescription
[14C] AZD6738DRUGradiolabeled AZD6738 / ceralasertib
AZD6738 / ceralasertibDRUGCeralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase ATR
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF. Type of Partic...

Countries:United Kingdom
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Competitive Landscape -Myeloproliferative Neoplasms 53 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536, Luspatercept, Fedratinib, BMS-986158, Ruxolitinib
AbbVie, Inc.ABBV4PHASE3Navitoclax, Ruxolitinib, Celecoxib, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib, Pacritinib, Momelotinib
Geron CorporationGERN2PHASE3Imetelstat, Ruxolitinib
Incyte CorporationINCY11PHASE2itacitinib, Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2MMB, Momelotinib, Luspatercept
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06754761primaryCompletionDate: changed
LOWMay 24, 2026NCT06754761studyFirstPostDate: changed