NCT05519449招募中1 期
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 272
- 试验地点
- 64
- 主要终点
- Incidence of Dose Limiting Toxicities (DLT)
研究概览
简要总结
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥18 years of age at the time of signing informed consent
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
- •Adequate organ function
- •For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
- •For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings
- •For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor
- •For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
排除标准
- •Prior solid organ transplant
- •Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
- •Clinically significant cardiovascular disease
- •For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
- •For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
- •For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
- •For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
- •Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
- •Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
研究组 & 干预措施
Combination Expansion
Experimental
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose
干预措施: Darolutamide (Drug)
Combination Expansion
Experimental
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose
干预措施: JANX007 (Biological)
Dose Escalation
Experimental
IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
干预措施: JANX007 (Biological)
Monotherapy Expansion Parts A - D
Experimental
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
干预措施: JANX007 (Biological)
Backfill Expansion
Experimental
IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
干预措施: JANX007 (Biological)
结局指标
主要结局
Incidence of Dose Limiting Toxicities (DLT)
时间窗: 3 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
时间窗: 3 years
次要结局
- Area under the concentration time curve to infinity of JANX007 (AUC0-inf)(Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years))
- Maximum observed concentration of JANX007 (Cmax)(Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years))
- Number of participants who develop anti-drug antibodies against JANX007(Up to 3 years)
- Duration of Response(Up to 3 years)
- Prostate Specific Antigen (PSA) response(Up to 3 years)
- Radiographic Progression Free Survival (rPFS)(Up to 3 years)
- Overall Response Rate(Up to 3 years)
- Overall Survival(Up to 3 years)
研究者
研究点 (64)
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