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MechanismIntegrin modulators |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价TB01在晚期结直肠癌患者中的安全性及有效性的单臂、开放的多中心II期临床研究
[Translation] A single-arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of TB01 in patients with advanced colorectal cancer
主要目的:
评价TB01在 晚期结直肠癌 患者中的 抗肿瘤效应 。
次要目的:
1) 评价 TB01在晚期 结直肠癌 患者中的药代动力学( PK)特征
2)评价 TB01在晚期 结直肠癌 患者中的 安全性及耐受性 。
探索性目的:
1) 探索肿瘤组织中整合素的表达情况与疾病预后的相关性;
2) 探索体内细胞因子及其受体(VEGF、VEGFR)在用药前后的变化及其与疾病预后的相关性;
3) 探索TB01在晚期结肠癌患者中的免疫原性及抗药抗体(ADA)产生对PK、有效性和安全性的影响。
[Translation] main purpose:
To evaluate the antitumor effect of TB01 in patients with advanced colorectal cancer.
Secondary purpose:
1) To evaluate the pharmacokinetic (PK) characteristics of TB01 in patients with advanced colorectal cancer
2) To evaluate the safety and tolerability of TB01 in patients with advanced colorectal cancer.
Exploratory Purpose:
1) To explore the correlation between the expression of integrins in tumor tissue and disease prognosis;
2) To explore the changes of cytokines and their receptors (VEGF, VEGFR) in vivo before and after treatment and their correlation with disease prognosis;
3) To explore the immunogenicity of TB01 in patients with advanced colon cancer and the effect of anti-drug antibody (ADA) production on PK, efficacy and safety.
评估注射用HYD-PEP06在实体瘤患者中安全性、耐受性和药代动力学—一项单中心、单臂、单次及多次给药的I期临床试验
[Translation] Evaluating the safety, tolerability and pharmacokinetics of HYD-PEP06 for injection in patients with solid tumors—a single-center, single-arm, single- and multiple-dose Phase I clinical trial
主要目的
评价注射用HYD-PEP06在晚期实体瘤患者中单次给药及多次给药的耐受性和安全性,确定其最大耐受剂量(MTD)和剂量限制性毒性(DLT)。
次要目的
(1)评价注射用HYD-PEP06在晚期实体瘤患者中的药代动力学特征;
(2)初步评估注射用HYD-PEP06治疗晚期实体瘤患者的有效性;
探索性目的
(1)初步探索注射用HYD-PEP06在人体的免疫原性反应及抗药抗体产生对PK/PD、有效性和安全性的影响;
(2)初步探索注射用HYD-PEP06对细胞因子EGF/VEGF的影响。
[Translation] main purpose
To evaluate the tolerability and safety of single-dose and multiple-dose of HYD-PEP06 for injection in patients with advanced solid tumors, and to determine its maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
secondary purpose
(1) To evaluate the pharmacokinetics of HYD-PEP06 for injection in patients with advanced solid tumors;
(2) Preliminary evaluation of the efficacy of HYD-PEP06 for injection in the treatment of patients with advanced solid tumors;
exploratory purpose
(1) Preliminary exploration of the immunogenic response of HYD-PEP06 for injection in humans and the effect of anti-drug antibody production on PK/PD, efficacy and safety;
(2) Preliminarily explore the effect of HYD-PEP06 for injection on cytokines EGF/VEGF.
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