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AZD4547

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Dec 29, 2025

Success Probability

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Trial Design

UNCONTROLLEDDMC

Total Trials1

Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

AZD4547 · 3 trials · 5 indications

Phase 1 3

Indication

NCT02546661Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder CancerMuscle Invasive Bladder Cancer

ACTIVE NOT_RECRUITING117 Analytics

NCT01202591Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer PatientsFGFR Inhibition, Pharmacokinetics, Biomarkers

COMPLETED127 Analytics

NCT01213160Study to Assess Safety and Tolerability of AZD4547 in Japanese PatientCancer

COMPLETED40 Analytics

PHASE1ACTIVE NOT_RECRUITING

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

Muscle Invasive Bladder Cancer

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PHASE1COMPLETED

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

FGFR Inhibition, Pharmacokinetics, Biomarkers

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PHASE1COMPLETED

Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

Cancer

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Study Endpoints

Primary Endpoints

Module A: The frequency and nature of adverse events related to AZD4547 monotherapy.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of AZD4547 monotherapy given orally to selected patients with MIBC who have progressed following prior therapy.

Module A: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral AZD4547.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) given intravenously in combination with AZD4547 given orally to selected patients with MIBC who have progressed following prior therapy.

Module B: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral olaparib.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) given intravenously in combination with olaparib given orally to selected patients with MIBC who have progressed following prior therapy.

Module C: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral AZD1775.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) given intravenously in combination with AZD1775 given orally to selected patients with MIBC who have progressed following prior therapy.

Module D: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) monotherapy.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) monotherapy given intravenously to selected patients with MIBC who have progressed following prior therapy.

Module E: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral vistusertib.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI 4736 (durvalumab) given intravenously in combination with vistusertib given orally to selected patients with MIBC who have progressed following prior therapy.

Module F: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and intravenous AZD9150.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of intravenous MEDI4736 (durvalumab) in combination with intravenous AZD9150 in selected patients with MIBC who have progressed following prior therapy.

Module G: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral selumetinib.

Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.

The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI 4736 (durvalumab) given intravenously in combination with selumetinib given orally to selected patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in clinical chemistry parameters.

Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation.

Changes from baseline in clinical chemistry parameters will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in haematology parameters.

Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation.

Changes from baseline in haemotology parameters will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in urinalysis results.

Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation.

Changes from baseline in urinalysis findings will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in vital signs.

Day 1 of Cycles 1, 2, 3, and 4 and every 4 weeks therafter, and at discontinuation.

Changes from baseline in vital signs will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in physical examination findings.

Day 1 of Cycles 1, 2, 3, and 4 and every 4 weeks therafter, and at discontinuation.

Changes from baseline in physical examination findings will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in ECG findings.

ECGs will be collected at screening, Day 1, Cycle 1and then Day 1 of each cycle from Cycle 2 onwards.

Changes from baseline in ECG findings will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in ejection fraction determined by assessing ECHO/MUGA scans.

Ejection fraction will be measured at screening, on Day 1, Cycle 1, and every 12 weeks thereafter (relative to the first dose of study drug) up to Cycle 7, and then every 16 weeks thereafter.

Changes from baseline in ejection fraction determined by assessing ECHO/MUGA scans will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in coagulation parameters

Coagulation parameters will be measured at screening, on Day 1, Cycle 1, and every 12 weeks thereafter (relative to the first dose of study drug) up to Cycle 7, and then every 16 weeks thereafter.

Changes from baseline in coagulation parameters will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

All Modules: Change from baseline in lipid profile

Lipid profile will be measured at screening, on Day 1, Cycle 1, and every 12 weeks thereafter (relative to the first dose of study drug) up to Cycle 7, and then every 16 weeks thereafter.

Changes from baseline in lipid profile will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy.

Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)

3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).

Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination

General examination prior to IP administration in treatment cycles

Assessment of adverse events (based on CTCAE version 4.0)general examination

General examination on day 1 in cycle 0

Assessment of adverse events (based on CTCAE version 4.0), laboratory values

Laboratory assessment prior to IP administration in all treatment cycles

Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements

Vital sign measurements prior to IP administration in all treatment cycles

Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)

LVEF prior to study administration

Assessment of adverse events (based on CTCAE version 4.0), LVEF

LVEF on day 21 in cycle 1.

Assessment of adverse events (based on CTCAE version 4.0), eye examination

Eye examination prior to study administration

Secondary Endpoints

Objective response rate (ORR)

16 weeks and 52 weeks

Disease control rate (DCR)

16 weeks and 52 weeks

Progression free survival (PFS)

up to 12 months

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Module A: AZD4547 Monotherapy	EXPERIMENTAL	AZD4547 will be given orally twice daily until disease progression. Patients who receive AZD4547 as monotherapy will have the option to cross over to durvalumab as monotherapy at the point of objective progression, as long as the following criteria are met: * The investigator believes it is in the patient's interest to receive durvalumab; * The patient consents to the continued treatment; * It is clinically appropriate for the patient to continue on durvalumab treatment; * The patient satisfies the key eligibility criteria for receiving durvalumab treatment.
Module A: MEDI4736 (durvalumab) + AZD4547	EXPERIMENTAL	AZD4547 will be given orally twice daily until disease progression. Patients will also receive MEDI 4736 (durvalumab) by IV infusion once every 4 weeks.
Module B: MEDI4736 (durvalumab) + Olaparib	EXPERIMENTAL	MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. Olaparib will be given orally twice daily.
Module C: MEDI4736 (durvaluamb) + AZD1775	EXPERIMENTAL	MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. AZD1775 will be given orally in approximate 12 hour intervals over 3 days (6 doses) on Days 1-3, 8-10, and 15-17 of 28 day cycles.
Module D: MEDI4736 (durvalumab) monotherapy	EXPERIMENTAL	MEDI 4736 (durvalumab) will be given by IV infusion once every 4 weeks.
Module E: MEDI4736 (durvalumab) + Vistusertib	EXPERIMENTAL	MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. Vistusertib will be given orally twice per day on an intermittent schedule (2 days on, 5 days off).
Module F: MEDI4736 (durvaluamb) + AZD9150	EXPERIMENTAL	AZD9150 will be given as monotherapy on Days -7, -5, and -3 of a one week lead-in period. Combination dosing with IV AZD9150 followed by IV MEDI4736 (durvalumab) begins on Day 1 of each 28 day cycle. Thereafter AZD9150 is given weekly and MEDI4736 is given once every 4 weeks.
Module G: MEDI4736 + Selumetinib	EXPERIMENTAL	-
AZD4547 + exemestane	EXPERIMENTAL	Safety run-in: AZD4547 plus exemestane
AZD4547 + fulvestrant	EXPERIMENTAL	A Randomised phase IIa: AZD4547 plus fulvestrant
Placebo + fulvestrant	PLACEBO_COMPARATOR	Randomised phase IIa: Matching placebo plus fulvestrant
AZD4547	EXPERIMENTAL	-

Interventions

Name	Type	Description
AZD4547	DRUG	AZD4547 Monotherapy vs. MEDI4736 (durvalumab) + AZD4547 1:1 Randomization.
MEDI4736	DRUG	MEDI4736
Olaparib	DRUG	MEDI4736 (durvalumab) + Olaparib
AZD1775	DRUG	MEDI4736 (durvalumab) + AZD1775
Vistusertib	DRUG	MEDI4736 (durvalumab) + Vistusertib
AZD9150	DRUG	MEDI4736 (durvalumab) + AZD9150
Selumetinib	DRUG	MEDI4736 (durvalumab) + Selumetinib
Exemestane	DRUG	Tablet oral once daily
Placebo	DRUG	Tablet oral twice daily
Fulvestrant	DRUG	A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration

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Eligibility Criteria

Age Range18 Years to 130 Years

SexALL

Healthy VolunteersNo

Study Sites27

Inclusion Criteria for all Modules: 1. Metastatic MIBC 2. 2nd/3rd line 3. Failed adjuvant/neo-adjuvant chemotherapy \<1 yr 4. 1 lesion ≥10 mm at baseline in the longest diameter suitable for accurate repeated measurement 5. WHO perf. status 0-1 For Module A: 1. M/F ≥25 2. Confirmation of FGFR3 mu...

Countries:United StatesCanadaFranceSpainUnited KingdomBelgiumCzechiaGermanyHungaryItalyRomaniaJapan

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Competitive Landscape -Cancer 5 trials

Company	Ticker	Trials	Lead Phase	Drugs
GE Healthcare Technologies Inc.	GEHC	1	PHASE1	GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.	ZBH	1	-	Undisclosed
Ascentage Pharma Group International Unsponsored ADR	AAPG	1	PHASE1	Olverembatinib

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Frequently asked questions about AZD4547

What is AZD4547 used for?

AZD4547 is an investigational small molecule being studied for use in oncology, including ER+ breast cancer, advanced solid malignancies, and muscle invasive bladder cancer. It is also being evaluated for FGFR inhibition, pharmacokinetics, and biomarkers. AZD4547 is in Phase 1 clinical development and is not yet approved.

What does AZD4547 target?

AZD4547 targets FGFR, or fibroblast growth factor receptor. It is being studied as an FGFR inhibitor in clinical trials for conditions such as ER+ breast cancer and muscle invasive bladder cancer. The drug is designed to interfere with FGFR signaling pathways involved in cancer growth.

Who makes AZD4547?

AZD4547 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of AZD4547 in various cancer indications.

What phase is AZD4547 in?

AZD4547 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety, tolerability, and efficacy in cancer patients.

What clinical trials is AZD4547 in?

AZD4547 has been studied in several Phase 1 trials. NCT01202591 evaluated AZD4547 with fulvestrant in ER+ breast cancer. NCT01213160 assessed safety in Japanese patients with advanced solid malignancies. NCT02546661 is an active trial in muscle invasive bladder cancer, with a total enrollment of 127 across these studies.

Is AZD4547 the same as other FGFR inhibitors?

AZD4547 is a specific FGFR inhibitor developed by AstraZeneca. It is not the same as other FGFR inhibitors, as each drug has a unique chemical structure and profile. AZD4547 is being studied independently in clinical trials for its safety and efficacy in cancer treatment.