Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biodistribution and Antitumour Activity of the Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- ARTBIO Inc.
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- To determine the safety and tolerability profile of AB001 in participants with mCRPC
研究概览
简要总结
This Phase 1 study will evaluate the safety, tolerability, and preliminary effectiveness of AB001, an alpha-emitting radioligand targeting prostate-specific membrane antigen (PSMA), in patients with advanced prostate cancer who are either 177Lu-PSMA naïve or experienced. The study includes dose escalation to identify a recommended dose and dose expansion to further assess safety and anti-tumour activity. Primary objectives are to characterize the safety profile and determine the optimal dose and schedule for future studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants at least 18 years of age
- •ECOG PS of 0 to 2
- •Progressive mCRPC
- •Previous treatment with at least one novel ARPI
- •Prior orchiectomy and/or prior or ongoing androgen-deprivation therapy
- •Prior treatment with at least one taxane regimen or patient refusing or considered appropriate by treating physician to delay taxane therapy
- •177Lu-PSMA experienced Group only: Prior treatment with at least one dose of 177Lu-PSMA
- •At least one PSMA-avid distant metastatic lesion
- •Adequate bone marrow, renal, and hepatic function
排除标准
- •Blockage in the bladder or kidneys
- •Untreated or uncontrolled brain metastases. Treated brain metastases are permitted provided they are neurologically stable
- •Symptomatic, or clinical or radiologic findings indicative of impending cord compression.
- •History of myelodysplastic syndrome (MDS), treatment-related acute myeloid leukaemia or features suggestive of MDS/acute myeloid leukaemia.
- •A known additional malignancy that has required active treatment within the past two years before start of study treatment, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy
研究组 & 干预措施
AB001 treated ¹⁷⁷Lu-PSMA naïve mCRPC patients
Dose Escalation will be initiated in ¹⁷⁷Lu-PSMA naïve mCRPC patients with the first cohort of participants receiving a starting dose of 100 MBq Pb212 (AB001) administered by slow injection on Day 1 of a 6-week (42-day) cycle. Four cycles of study treatment are planned; however, individual participants may continue up to a maximum of six treatment cycles provided they meet defined criteria. Subsequent cohorts of 177Lu-PSMA naïve participants will be opened for dose finding and schedule optimisation.
干预措施: AB001 (Drug)
AB001 treated 177Lu-PSMA experienced mCRPC patients
For the 177Lu-PSMA experienced Group, the first cohort will initiate enrolment with a starting dose of 100 MBq Pb212 (AB001) administered by slow injection on Day 1 of a 6-week (42-day) cycle. Four cycles of study treatment are planned; however, individual participants may continue up to a maximum of six treatment cycles provided they meet defined criteria. Subsequent cohorts of 177Lu-PSMA experienced participants will be opened for dose finding and schedule optimisation.
干预措施: AB001 (Drug)
结局指标
主要结局
To determine the safety and tolerability profile of AB001 in participants with mCRPC
时间窗: From enrolment to active follow-up at 12 months post end of treatment
Incidence and severity of TEAEs (including AESIs and TESAEs)
Dose Escalation: To determine recommended AB001 Dose (MBq) in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for Dose Expansion
时间窗: For 177Lu-PSMA naïve group: Anticipated after 20 evaluable participants; ~1 year from FPFV in this group. For 177Lu-PSMA experienced group: Anticipated after 20 evaluable participants, ~1 year from FPFV in this group
The recommended dose (MBq) of AB001 for dose expansion in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour activity assessments (including incidence of DLTs and PSA50 response). The multiple measurements will be aggregated by the study team to select a single recommended dose. Single Outcome Measure Value (Units): Dose in MBq
Dose Escalation: To determine recommended AB001 Schedule (frequency of dose in cycles/weeks) in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for Dose Expansion
时间窗: Time Frame- For 177Lu-PSMA naïve group: Anticipated after 20 evaluable participants; ~1 year from FPFV in this group. For 177Lu-PSMA experienced group: Anticipated after 20 evaluable participants, ~1 year from FPFV in this group
The recommended AB001 Schedule (frequency of dose in cycles/weeks) for dose expansion in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour activity assessments (including incidence of DLTs and PSA50 response). The multiple measurements will be aggregated by the study team to select a single recommended AB001 Schedule. Single Outcome Measure Value (Units): AB001 Schedule in Cycles/weeks
Dose Expansion: To assess the recommended Dose (MBq) determined in Dose Escalation in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for further clinical development of AB001
时间窗: In each group treated with selected dose, anticipated after 20 evaluable participants, ~1 year from FPFV in each group.
The recommended dose (MBq) of AB001 for further clinical development of AB001 in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour efficacy (including incidence and severity of \[S\]AEs, PSA50 response, and ORR). The multiple measurements will be aggregated by the study team to select a single recommended dose. Single Outcome Measure Value (Units): Dose in MBq
Dose Expansion: To assess the recommended AB001 Schedule (frequency of dose in cycles/weeks) determined in Dose Escalation in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for further clinical development of AB001
时间窗: In each group treated with selected schedule, anticipated after 20 evaluable participants, ~1 year from FPFV in each group.
The recommended schedule of AB001 for further clinical development of AB001 in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour efficacy (including incidence and severity of \[S\]AEs, PSA50 response, and ORR). The multiple measurements will be aggregated by the study team to select a single recommended schedule of AB001. Single Outcome Measure Value (Units): AB001 Schedule in Cycles/weeks
次要结局
未报告次要终点