Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

AZD0754 monotherapy for treatment of participants with metastatic prostate cancer.

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD0754.

During AZD0754 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD0754 product, subjects will receive treatment with AZD0754 therapy.

Study treatment will include lymphodepleting chemotherapy followed by one dose of AZD0754 administered by intravenous (IV) infusion.

AZD0754

AstraZeneca Clinical Study Information Center

The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer.

This is a first-time in human, multi-center, open label, Phase I/II study of AZD0754 autologous CAR T-cell therapy administered intravenously to participants with metastatic prostate cancer. The study is intended to assess the safety, cellular kinetics, pharmacodynamics, preliminary efficacy, and feasibility of manufacturing AZD0754 for patients with metastatic prostate cancer.

Study of AZD0754 in Participants With Metastatic Prostate Cancer

A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, a Chimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participants With Metastatic Prostate Cancer: APOLLO

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Determine if treatment with AZD0754 is safe and tolerable through assessment of DLTs/DLT-like events, AEs, AESIs, SAEs, and changes from baseline in laboratory parameters, vital signs, and ECGs.

Number of patients with positive RCL sample

PSA50 response rate is defined as the proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.

PSA90 response rate is defined as the proportion of participants achieving a ≥ 90% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.

Time from the date of first documented PSA50 and PSA90 until the date of documented PSA progression or death due to any cause in the absence of PSA progression.

Percentage of participants who have a confirmed PSA50 and PSA90 response with a duration of at least 6 months.

Time from AZD0754 infusion date until the date of the first documented PSA50 and PSA90 response.

Time from the date of first documented PSA50 and PSA90 response until the date of documented PSA progression.

Best overall radiological visit response the participant achieves per RECIST V1.1 and PCWG3.

Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR).

Time from AZD0754 infusion date until date of first documented evidence of CR or PR.

Time from the date of first documented evidence of CR or PR until date of first documented disease progression or death.

Percentage of participants who have a confirmed response (CR/PR) with a duration of at least 6 months.

Percentage of participants who have a confirmed CR, PR, or Stable Disease (SD) for at least 11 and 23 weeks after AZD0754 infusion.

Percentage change in tumor size from baseline per RECIST V1.1 and PCWG3.

Time from AZD0754 infusion until date of objective disease progression according to RECIST V1.1 and PCWG3 criteria.

Time from AZD0754 infusion until death due to any cause

Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Event (SSRE).

Time taken to reach maximum serum concentration

Time of last measurable serum concentration

Investigate STEAP2 expression in tumor as measured by IHC.

Spots Global Cancer Trial Database for Study of AZD0754 in Participants With Metastatic Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

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