NCT05405439终止1 期
Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients 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
- 终止
- 入组人数
- 39
- 试验地点
- 23
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.
详细描述
This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 18 to
- •Subjects with pathologically proven with prostate adenocarcinoma.
- •Metastatic disease confirmed by imaging (eg, bone scan and CT/MRI).
- •The patient's serum testosterone level at the screening visit was ≤ 1.73 nmol/L (50 ng/dL). Patients who did not undergo bilateral orchiectomy required continued ADT [gonadotropin-releasing hormone analog (LHRHa, agonist/antagonist)] treatment throughout the study period.
- •Disease progression during consecutive androgen deprivation therapy (ADT), defined at study entry, as meeting one or more of the following criteria:
- •At least two consecutive PSA elevations separated by at least 1 week, the last result must be at least 1.0 ng/mL.
- •Soft tissue lesion progression as assessed by RECIST 1.1 with or without PSA progression.
- •Bone disease progression assessed by PCWG3, i.e., ≥2 new lesions detected on bone scan, ≥2 new bone lesions other than those previously assessed on reassessment at least 8 weeks later, with ≥2 previously assessed bone lesions still exist, regardless of PSA progression.
- •Patients must discontinue all prior cancer therapy (except ADT and bone loss prophylaxis) and have recovered to ≤ Grade 1 or baseline (according to the Common Terminology Criteria for Adverse Events) prior to first dose of all acute toxic effects of prior therapy or surgery Version 5.0 [CTCAE v 5.0]), with the exception of alopecia and peripheral neuropathy, and the washout period since the last prior systemic or radiation therapy was as follows:
- •At least 4 weeks must have elapsed since enrollment with 5-alpha reductase inhibitors (eg, dutasteride, finasteride), estrogen, and cyproterone.
- •At least 4 weeks must have elapsed from major surgery or radiation therapy to enrollment。
- •Laboratory indicators meet the requirements.
排除标准
- •For subjects with brain metastases with symptoms or symptom control for less than 1 month, screening for CNS metastases at baseline is not required unless there are signs and/or symptoms of CNS involvement.
- •Subjects who have developed or is currently suffering from other malignancies within 3 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
- •Subjects who have accepted botanicals (such as saw palmetto) that may lower PSA levels within 4 weeks before the first dose.
- •Subjects who have accepted oral targeted drugs within 5 drug half-lives from the first dose (calculated from the end of the last treatment).
- •Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
- •Subjects who have previously accepted CYP17 enzyme inhibitors (including drugs such as abiraterone, TAK-700, TOK-001, and ketoconazole, ect.,) or second generation androgen receptor inhibitors (including enzalutamide, apalutamide, darolutamide , etc.) (mHSPC, nmCRPC stage).
- •The study accept patients who received McRpc-based chemotherapy with CYP17 inhibitors other than abiraterone or second-generation androgen receptor inhibitors or paclitaxel for less than 3 months without disease progression, However, 4 weeks or 5 half-life washing out period is required (whichever is longer).
- •Patients who received abiraterone in the mCRPC phase for less than 3 months and did not progress (no need to stop elution) are allowed in the study, but cannot be enrolled in the phase I cohort of a single drug population in this study.
- •Patients who received ADT+ paclitaxel chemotherapy, ADT+ 1st generation androgen receptor inhibitors (e.g. Flutamide, bicalutamide, nilutamide, etc.), ADT+ERBT (external radiation therapy) in mHSPC phase will be acceptable in the study, provided that they met the exclusion criteria
- •Subjects who receive medications known to be potent inhibitors of cytochrome P450 3A4 (CYP3A4) or potent or moderate inducers and unable to discontinue these medications or switch to another for at least 5 half-lives prior to initiation of study medication different medicines.
- •Subjects who suffer from contraindications to prednisone (corticosteroid) use, such as active systemic infection (e.g. bacterial infection requiring intravenous antibiotics at initiation of study treatment, fungal infection, or detectable viral infection requiring systemic therapy ) or viral load (e.g. known HIV positive or known active hepatitis B or C (e.g. hepatitis B surface antigen positive). Screening for contraindications other than HIV/HBV and HCV is not required to determine eligibility.
- •Subjects with history of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest CT scan during screening.
- •Subjects with any chronic condition requiring corticosteroid treatment at doses greater than "Prednisone 5mg, BID";
研究组 & 干预措施
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets
Experimental
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.
干预措施: TQB3823 tablets (Drug)
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets
Experimental
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.
干预措施: Abiraterone acetate tablets (Drug)
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets
Experimental
TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.
干预措施: prednisone acetate tablets (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: Up to 4 weeks
The relevant adverse reactions occurred within the first cycle
Recommended phase II dose (RP2D)
时间窗: Up to 8 weeks
The dose of TQB3823 tablet which is recommended to use during phase II clinical trial
The ratio of subject radiographic progression-free survival for 12 months
时间窗: For 12 months
Proportion of subjects without disease progression assessed by radiology within 12 months
Adiographic progression-free survival (rPFS)
时间窗: Up to 24 months
rPFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause evaluated by radiological examination
次要结局
- The ratio of subject radiographic progression-free survival for 12 months(For 6 months)
- The ratio of prostate specific antigen (PSA) reduction(Up to 24 months)
- Overall response rate (ORR) based on 2014 Lugano(Up to 24 months)
- Overall survival (OS)(Up to death)
- Clinical benefit rate (CBR)(Up to 24 months)
- Duration of Response (DOR)(Up to 24 months)
- time to bone-related event(Up to 24 months)
- Time to PSA progression(Up to 24 months)
- Peak time (Tmax)(Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days))
- Peak concentration (Cmax)(Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days))
- Half-life /T1/2(Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days))
- Adverse event rate(Baseline up to 24 months)
研究者
研究点 (23)
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