Clinical Trials List
Protocol NumberCAAA817A12201
NCT Number(ClinicalTrials.gov Identfier)NCT06780670
Active
2025-02-03 - 2033-05-03
Phase II/III
Recruiting4
一項第 II/III 期、開放性、跨國、多中心、隨機分配試驗，在 [177Lu]Lu-PSMA 精準放射標靶療法期間或之後惡化的 PSMA 陽性轉移性去勢抗性前列腺癌成人參與者中，比較 AAA817 相較於標準照護的治療
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis (Taiwan) Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 呂育全 無
- JIAN-HUA HONG 無
- CHUNG-HSIN CHEN 無
- 闕士傑 無
- 王中傑 無
- 邱士庭 無
- JHE-CYUAN GUO 無
- JEI-YIE HUANG 無
- FU-JEN HSUEH 無
- PO-MING CHOW 無
- 莊佩儒 無
- - - 無
- Yu-Chieh Tsai 無
- 沈盈君 無
- 張晉誠 無
- 曾啟新 無
- Yeong-Shiau Pu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 沈書慧 Division of Radiology
- 康鈺玫 無
- Tzu-Ping Lin Division of Urology
- 陳威任 無
- 沈書慧 無
- 林可瀚 無
- Jiun-I Lai 無
- Hsiao-Jen Chung 無
- Tzu-Hao Huang 無
- 蔡承翰 無
- 彭南靖 無
- William Huang 無
- Tzu-chun Wei 無
- Tzu-Hsiang Hsu 無
- Yu-Ming Liu 無
- Yen-Hwa Chang 無
- Chih-Chieh Lin 無
- Ming-Hsuan Ku 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
See-Tong Pang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
PSMA-positive metastatic castration-resistant prostate cancer
Objectives
Study consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support the proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this study is to collect additional information to support proposed phase III dose of AAA817.
Test Drug
AAA817
Active Ingredient
[225 Ac]Ac-PSMA-617
Dosage Form
Infusion Solution
Dosage
8 or 10 MBq
Endpoints
phase II
● Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
● Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
● Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
phase III
● Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
● Percentage of participants who are alive or who are lost to follow-up at the time of analysis
● Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
● Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
● Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
phase III
● Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
● Percentage of participants who are alive or who are lost to follow-up at the time of analysis
Inclution Criteria
Inclusion Criteria: ∙
• adults ≥ 18 years of age.
• ECOG performance status of 0 to 2.
• histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
• PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
• castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
• Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
• ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
• eGFR as requested by the sponsor
• adults ≥ 18 years of age.
• ECOG performance status of 0 to 2.
• histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
• PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
• castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
• Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
• ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
• eGFR as requested by the sponsor
Exclusion Criteria
Exclusion Criteria:
• Any investigational agents within 28 days prior to the day of randomization.
• Any 225Ac-based investigational compound used prior to the day of randomization.
• Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
• Baseline xerostomia ≥ Grade 2 by CTCAE v.5
• History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
Other protocol-defined inclusion/exclusion criteria may apply.
• Any investigational agents within 28 days prior to the day of randomization.
• Any 225Ac-based investigational compound used prior to the day of randomization.
• Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
• Baseline xerostomia ≥ Grade 2 by CTCAE v.5
• History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
Other protocol-defined inclusion/exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
432 participants
