2025-523273-41-00招募中2 期
A Phase 1/2 dose escalation trial with administration schedule exploration evaluating single agent TD001, a PSMA-targeted antibody-drug conjugate, in patients with PSMA-expressing metastatic castration-resistant prostate cancer
T.O.A.D. Oncology S.A.3 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年1月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Incidence and severity of DLTs during Cycle 1 (dose escalation only)
研究概览
简要总结
Dose Escalation • To determine the MTD and RP2Ds of administration schedules of TD001 • To evaluate the safety and tolerability of administration schedules of TD001 Dose Expansion • To evaluate the safety and tolerability of the RP2D(s) of TD001 with administration schedules
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult males with documented progressive mCRPC based on at least one of the following: o Serum PSA progression. o Soft-tissue or visceral progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) with Prostate Cancer Working Group 3 (PCWG3). o Progression of bone disease (2+2 PCWG3 criteria).
- •At least one measurable metastatic lesion per RECIST 1.
- •Prior orchiectomy and/or ongoing ADT
- •Received at least one androgen receptor pathway inhibitor (ARPI) and at least one but no more than two taxane agents (or be unsuitable for treatment). Participants with a homologous recombination repair (HRR) gene mutation must have received a poly (ADP-ribose) polymerase (PARP) inhibitor (or be unsuitable for treatment)
排除标准
- •Previous treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation, within 6 months prior to treatment start.
- •Systemic anticancer therapy including an investigational agent within 28 days prior to treatment start.
- •Known hypersensitivity to the components of the trial drug, its analogs, or excipients
结局指标
主要结局
Incidence and severity of DLTs during Cycle 1 (dose escalation only)
Incidence and severity of DLTs during Cycle 1 (dose escalation only)
Incidence, severity, and relationship of AEs and SAEs
Incidence, severity, and relationship of AEs and SAEs
Laboratory parameters
Laboratory parameters
Treatment discontinuations and treatment modifications due to AEs
Treatment discontinuations and treatment modifications due to AEs
次要结局
- Plasma concentration profile parameters (AUC, AUClast, AUCtau, Cmax, Tmax, T1/2, and Ctrough) of total ADC, total antibody, and unconjugated exatecan payload
- Safety and efficacy endpoints
- PSA50 response rate
- ORR by investigator assessment
- PSA PFS
- Radiographic PFS by investigator assessment
- Duration of response (PSA and radiographic by investigator assessment)
- Disease control rate
- Overall survival
- Prevalence and plasma titers of ADA against TD001
研究者
Mohamed Bekradda
Scientific
T.O.A.D. Oncology S.A.
研究点 (3)
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