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AZD6621

Phase 1

Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

AZD6621 · 1 trial · 1 indication

Phase 1 1
NCT07192614A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate CancerProstate Cancer
RECRUITING52 Analytics
PHASE1RECRUITING
A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)

• Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results

Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
From first study dose to 21 to 28 days post first dose

• 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.

Preliminary anti-tumour activity of AZD6621 (PSA Response Rate) (Part B only)
Up to 3 years

• Number of participants with a PSA response rate

Secondary Endpoints

Preliminary anti-tumour activity of AZD6621 (PSA Response rate) (Part A only)
Up to 3 years
Preliminary anti-tumour activity of AZD6621 (time to PSA response)
Up to 3 years
Preliminary anti-tumour activity of AZD6621 (duration of PSA response)
Up to 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1 - Part A (Dose Escalation)EXPERIMENTALAZD6621 Monotherapy - Administration route 1
Module 2 - Part A (Dose Escalation)EXPERIMENTALAZD6621 Monotherapy - Administration route 2
Module 1/2 - Part B1 (Dose Expansion)EXPERIMENTALAZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
Module 1/2 - Part B2 (Dose Expansion)EXPERIMENTALAZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)

Interventions

NameTypeDescription
AZD6621DRUGA T Cell-engaging Antibody that targets STEAP2, CD3, and CD8
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites26

Inclusion Criteria 1. Capable of giving signed informed consent and complying to the study protocol. 2. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form. 3. ≥ 18 years of age at the time of signing the informed consent form. 4. Participants wi...

Countries:United StatesBelgiumCanadaChinaJapanNetherlandsSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Prostate Cancer 254 trials

Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT07192614lastUpdatePostDate: changed
LOWSep 2, 2026NCT07192614lastUpdatePostDate: changed
LOWSep 2, 2026NCT07192614lastUpdatePostDate: changed
LOWJul 29, 2026NCT07192614lastUpdatePostDate: changed
LOWJul 29, 2026NCT07192614lastUpdatePostDate: changed
LOWJun 9, 2026NCT07192614lastUpdatePostDate: changed
LOWJun 9, 2026NCT07192614lastUpdatePostDate: changed
LOWJun 9, 2026NCT07192614lastUpdatePostDate: changed
LOWJun 9, 2026NCT07192614lastUpdatePostDate: changed

Frequently asked questions about AZD6621

What is AZD6621 used for in prostate cancer?

AZD6621 is an investigational small molecule being studied for the treatment of metastatic prostate cancer in adult male patients. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does AZD6621 target?

The molecular target of AZD6621 has not been disclosed in available information. It is a small molecule modality being investigated for its safety, efficacy, and pharmacokinetics in patients with metastatic prostate cancer.

Who makes AZD6621?

AZD6621 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's potential in prostate cancer.

What phase is AZD6621 in?

AZD6621 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied for safety and effectiveness in patients.

What clinical trials is AZD6621 in?

AZD6621 is being evaluated in a Phase 1 clinical trial registered as NCT07192614. This study is recruiting adult male participants with metastatic prostate cancer across multiple countries, including the United States, Belgium, Canada, China, Japan, Netherlands, South Korea, Spain, and the United Kingdom.

Is AZD6621 the same as any other drug?

No alternative names for AZD6621 have been reported. It is identified solely by its developmental code name AZD6621 in clinical trial registries and scientific literature.