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AZD9750

Phase 1

Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 10, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

AZD9750 · 1 trial · 1 indication

Phase 1 1
NCT07336446A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer DrugsProstate Cancer
RECRUITING300 Analytics
PHASE1RECRUITING
A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
From first dose of study intervention to 28 days post first dose

To evaluate the safety and tolerability and determine the MTD and/or the RDE(s)/RP2D of AZD9750 as a monotherapy and in combination with other anticancer agents in participants with mCRPC. A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

Number of participants with Adverse Events and Serious Adverse Events
From first dose of study intervention up to 37 days after the last dose of study treatment

The number of participants with adverse events and with serious adverse events will be assessed.

Number of participants with Adverse Events leading to discontinuation of study intervention
From first dose of study intervention up to 37 days after the last dose of study treatment

The number of participants with clinically significant changes from baseline in vital signs will be assessed.

Clinically significant changes from baseline in vital signs.
From first study dose up to 37 days after the last dose of study treatment

The number of participants with clinically significant changes from baseline in vital signs will be assessed.

Clinically significant changes from baseline in physical examination.
From first dose of study intervention up to 37 days after the last dose of study treatment

The number of participants with clinically significant changes from baseline in physical examination will be assessed.

Clinically significant changes from baseline in ECOG PS.
From first dose of study intervention up to 37 days after the last dose of study treatment

The number of participants with clinically significant changes from baseline in ECOG PS will be assessed.

Clinically significant changes from baseline in ECGs.
From first dose of study intervention up to 37 days after the last dose of study treatment

The number of participants with clinically significant changes from baseline in ECGs will be assessed.

Clinically significant changes from baseline in laboratory parameters.
From first dose of study intervention up to 37 days after the last dose of study treatment

The number of participants with clinically significant changes from baseline in laboratory parameters will be assessed.

Proportion of participants achieving a ≥50% decrease in PSA from baseline (PSA50) (Part B only)
From first dose of study intervention up to 14 days after the last dose of study treatment

To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents in participants with mCRPC.

Secondary Endpoints

Proportion of participants achieving a ≥ 50% decrease in PSA from baseline (PSA50) (Part A only)
From first dose of study intervention up to initiation of subsequent anticancer therapy (or radiotherapy on target lesions), PSA progression or 14 days after the last dose of study treatment
Proportion of participants achieving a ≥ 90% decrease in PSA from baseline (PSA90)
From first dose of study intervention up to initiation of subsequent anticancer therapy (or radiotherapy on target lesions), PSA progression or 14 days after the last dose of study treatment
Objective response rate (ORR)
From randomisation or first dose of study intervention to initiation of subsequent anticancer treatment (or radiotherapy on target lesions) or progression, assessed up to 60 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1 / Part A1EXPERIMENTALAZD9750 Monotherapy (Dose Escalation) - No randomization
Module 1 / Part A2EXPERIMENTALAZD9750 Monotherapy (Backfills) - No randomization
Module 1 / Part B1EXPERIMENTALAZD9750 Monotherapy (Dose Optimization) - Randomization
Module 1 Part B2EXPERIMENTALAZD9750 Monotherapy (Dose Expansion) - No randomization
Module 1 / Part B3EXPERIMENTALAZD9750 Monotherapy (Dose Expansion) - No randomization
Module 2 / Part AEXPERIMENTALAZD9750 + Saruparib (Combination Dose Finding) - No Randomization
Module 2/ Part BEXPERIMENTALAZD9750 + Saruparib (Combination Dose Expansion) - No Randomization

Interventions

NameTypeDescription
AZD9750DRUGAR-PROTAC
AZD5305DRUGPARP1-selective inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites18

* Inclusion Criteria: * Participant must be ≥18 years or the legal age at the time of signing the informed consent form. * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate. * Documented metastatic disease. * Serum testosterone levels ≤ 50 ng/dL. * Evid...

Countries:United StatesAustraliaCanadaChinaJapanNetherlandsSpainUnited Kingdom
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Competitive Landscape -Prostate Cancer 254 trials

Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT07336446lastUpdatePostDate: changed
LOWAug 11, 2026NCT07336446lastUpdatePostDate: changed
LOWAug 11, 2026NCT07336446lastUpdatePostDate: changed
LOWJun 23, 2026NCT07336446lastUpdatePostDate: changed
LOWJun 23, 2026NCT07336446lastUpdatePostDate: changed

Frequently asked questions about AZD9750

What is AZD9750 used for in prostate cancer?

AZD9750 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development, where it is being evaluated for safety and effectiveness when given alone or with other anticancer drugs.

What does AZD9750 target?

The specific molecular target of AZD9750 has not been disclosed. It is a small molecule oncology drug, but its mechanism of action is not publicly detailed in the available clinical trial information.

Who makes AZD9750?

AZD9750 is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 trial to evaluate the drug in patients with metastatic prostate cancer.

What phase is AZD9750 in?

AZD9750 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being tested in a Phase 1 trial to assess its safety, tolerability, and preliminary efficacy in metastatic prostate cancer.

What clinical trials is AZD9750 in?

AZD9750 is being studied in a Phase 1 clinical trial with the identifier NCT07336446. This trial is recruiting male patients aged 18 years and older with metastatic prostate cancer, and it is being conducted in the United States, Australia, Canada, China, Japan, Netherlands, Spain, and the United Kingdom.