A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors.

Start Date02 Aug 2024

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

CTR20242543

/ RecruitingPhase 1

评价注射用 BL-M14D1 在局部晚期或转移性小细胞肺癌、神经内分泌肿瘤等实体瘤患者中的安全性、耐受性、药代动力学特征和初步疗效的 I 期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 for injection in patients with locally advanced or metastatic small cell lung cancer, neuroendocrine tumors and other solid tumors

1. 剂量递增阶段（Ia）1）主要目的：观察BL-M14D1在局部晚期或转移性小细胞肺癌、神经内分泌肿瘤等实体瘤患者中的安全性和耐受性，从而确定 MTD 和 DLT 。2）次要目的：评估BL-M14D1的药代动力学特征和免疫原性。2. 扩大入组阶段（Ib）1）主要目的：进一步观察BL-M14D1在Ia期推荐剂量下的安全性和耐受性，确定 RP2D 。2）次要目的：评估BL-M14D1的初步疗效、药代动力学特征和免疫原性。

[Translation]

1. Dose escalation phase (Ia) 1) Primary objective: To observe the safety and tolerability of BL-M14D1 in patients with locally advanced or metastatic small cell lung cancer, neuroendocrine tumors and other solid tumors, so as to determine the MTD and DLT. 2) Secondary objective: To evaluate the pharmacokinetic characteristics and immunogenicity of BL-M14D1. 2. Expansion phase (Ib) 1) Primary objective: To further observe the safety and tolerability of BL-M14D1 at the recommended dose of Phase Ia and determine the RP2D. 2) Secondary objective: To evaluate the preliminary efficacy, pharmacokinetic characteristics and immunogenicity of BL-M14D1.

Start Date02 Aug 2024

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

100 Clinical Results associated with BL-M14D1

100 Translational Medicine associated with BL-M14D1

100 Patents (Medical) associated with BL-M14D1

100 Deals associated with BL-M14D1

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Indication	Highest Phase	Country/Location	Organization	Date
Neuroendocrine Tumors	Phase 1	China	Sichuan Baili Pharmaceuticals Co.,Ltd	02 Aug 2024
Small Cell Lung Cancer	Phase 1	China	Sichuan Baili Pharmaceuticals Co.,Ltd	02 Aug 2024

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