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AZD6738

Phase 1

Neoplasm | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Sep 3, 2026

Target and mechanism

ModalitySmall molecule

Also known as [14C] AZD6738

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED

Total Trials1

Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

AZD6738 · 1 trial · 1 indication

Phase 1 1

NCT06754761Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of CeralasertibNeoplasm

TERMINATED2 Analytics

PHASE1TERMINATED

Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib

Neoplasm

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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 and recovery in urine and faeces

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

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) - Urine Ae

Through end of the part B, approximately 10 weeks (Including screening period)

Urine - Ae

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) - Urine CumAe

Through end of the part B, approximately 10 weeks (Including screening period)

Urine - CumAe

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) - Urine Fe

Through end of the part B, approximately 10 weeks (Including screening period)

Urine - Fe

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) - Urine CumFe

Through end of the part B, approximately 10 weeks (Including screening period)

Urine - CumFe

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) - Faeces Ae

Through end of the part B, approximately 10 weeks (Including screening period)

Faeces - Ae

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) - Faeces CumAe

Through end of the part B, approximately 10 weeks (Including screening period)

Faeces - CumAe

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) - Faeces Fe

Through end of the part B, approximately 10 weeks (Including screening period)

Faeces - Fe

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) - Faeces CumFe

Through end of the part B, approximately 10 weeks (Including screening period)

Faeces - CumFe

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) - Total (Urine+Faeces) Ae

Through end of the part B, approximately 10 weeks (Including screening period)

Total (Urine + Faeces) Ae

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) - Total (Urine+Faeces) CumAe

Through end of the part B, approximately 10 weeks (Including screening period)

Total (Urine + Faeces) CumAe

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) - Total (Urine+Faeces) Fe

Through end of the part B, approximately 10 weeks (Including screening period)

Total (Urine + Faeces) Fe

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) - Total (Urine+Faeces) CumFe

Through end of the part B, approximately 10 weeks (Including screening period)

Total (Urine + Faeces) CumFe

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 advanced solid tumours (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

Arm	Type	Description
Primary Treatment Arm - AZD6738	EXPERIMENTAL	Part A - oral dose of Ceralasertib and a radiolabelled IV microdose of \[14C\]-Ceralasertib Part B - oral dose of \[14C\]-Ceralasertib

Interventions

Name	Type	Description
[14C] AZD6738	DRUG	radiolabeled AZD6738 / ceralasertib
AZD6738 / ceralasertib	DRUG	Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase ATR

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Eligibility Criteria

Age Range18 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites1

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 52 trials (matched to "Neoplasm")

Company	Ticker	Trials	Lead Phase	Drugs
Bristol-Myers Squibb Company	BMY	5	PHASE3	ACE-536
AbbVie, Inc.	ABBV	4	PHASE3	Navitoclax, Ruxolitinib
Novartis AG Sponsored ADR	NVS	3	PHASE3	Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.	KPTI	4	PHASE3	Selinexor, Ruxolitinib
Geron Corporation	GERN	2	PHASE3	Imetelstat
Merck & Co., Inc.	MRK	1	PHASE3	Bomedemstat
Incyte Corporation	INCY	10	PHASE2	Ruxolitinib
GSK plc Sponsored ADR	GSK	2	PHASE2	MMB
Takeda Pharmaceutical Co. Ltd. Sponsored ADR	TAK	1	PHASE2	Elritercept, Ruxolitinib
Eli Lilly and Company	LLY	1	PHASE1	LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.	IRON	1	PHASE1	DISC-0974
Galecto, Inc.	GLTO	1	PHASE2	GB2064
Prelude Therapeutics, Inc.	PRLD	1	PHASE1	PRT12396
United Therapeutics Corporation	UTHR	1	PHASE2	bomedemstat

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Recent Changes (Last 90 Days)

CRITICALSep 3, 2026NCT06754761Status: NOT_YET_RECRUITING → TERMINATED

CRITICALSep 3, 2026NCT06754761Status: NOT_YET_RECRUITING → TERMINATED

Frequently asked questions about AZD6738

What is AZD6738 used for?

AZD6738, also known as ceralasertib, is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for oncology indications.

Who makes AZD6738?

AZD6738 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is in early-stage clinical research, with ongoing studies evaluating its properties in patients with neoplasms.

What phase is AZD6738 in?

AZD6738 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety, tolerability, and pharmacological characteristics in humans.

What clinical trials is AZD6738 in?

AZD6738 is being studied in a clinical trial registered as NCT06754761, titled "Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib." This Phase 1 study was conducted in the United Kingdom and enrolled participants aged 18 years and older.

Is AZD6738 the same as ceralasertib?

Yes, AZD6738 is also known as ceralasertib. In clinical research, the drug has been referred to by both names, and a study involving the drug is titled with the compound name [14C]-Ceralasertib (AZD6738), confirming that these names refer to the same investigational agent.