[Translation] Phase Ib/II clinical trial of the safety, tolerability and preliminary efficacy of KLT-1101 in patients with AIDS-related Kaposi sarcoma

主要目的：评价KLT-1101在AIDS-KS患者中的安全性、耐受性和初步疗效；确定KLT-1101在AIDS-KS患者中的II期推荐剂量（RP2D）。次要目的：评价KLT-1101在AIDS-KS患者中的药代动力学（PK）特征；评价KLT-1101在AIDS-KS患者中的免疫原性；评价KLT-1101的药物暴露水平与抗肿瘤疗效的相关性。探索性目的：探索KLT-1101药物暴露水平与安全性的相关性；探索KLT-1101抗肿瘤疗效相关的生物标志物随时间的变化；探索KLT-1101 PK/PD，以发现暴露浓度与效应细胞因子的相关性。

[Translation]

Primary objectives: To evaluate the safety, tolerability and preliminary efficacy of KLT-1101 in AIDS-KS patients; to determine the recommended Phase II dose (RP2D) of KLT-1101 in AIDS-KS patients. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of KLT-1101 in AIDS-KS patients; to evaluate the immunogenicity of KLT-1101 in AIDS-KS patients; to evaluate the correlation between drug exposure level and anti-tumor efficacy of KLT-1101. Exploratory objectives: To explore the correlation between drug exposure level and safety of KLT-1101; to explore the changes of biomarkers related to the anti-tumor efficacy of KLT-1101 over time; to explore KLT-1101 PK/PD to find the correlation between exposure concentration and effector cytokines.

Start Date23 Nov 2022

Sponsor / Collaborator

KANG LI TAI Pharmaceutical Co., Ltd.

CTR20201221

/ RecruitingPhase 1/2

KLT-1101在晚期实体瘤患者中的安全性、耐受性、药代动力学及初步疗效评价的Ib/II期临床研究

[Translation] A Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KLT-1101 in patients with advanced solid tumors

1、主要目的：评价KLT-1101在晚期实体瘤患者中的安全性和耐受性。 2、次要目的： 1) 评价KLT-1101在晚期实体瘤患者中的药代动力学特征； 2) 评价KLT-1101在晚期实体瘤患者中的药效学特征； 3) 评价KLT-1101在晚期实体瘤患者中对化疗引起的血细胞减少的疗效； 4) 评价KLT-1101在晚期实体瘤患者中的免疫原性。 3、探索性目的 1) 评价KLT-1101在晚期实体瘤患者中的抗肿瘤疗效。探索KLT-1101的临床推荐剂量.

[Translation]

1. Primary objective: To evaluate the safety and tolerability of KLT-1101 in patients with advanced solid tumors. 2. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of KLT-1101 in patients with advanced solid tumors; 2) To evaluate the pharmacodynamic characteristics of KLT-1101 in patients with advanced solid tumors; 3) To evaluate the efficacy of KLT-1101 on chemotherapy-induced hematopoiesis in patients with advanced solid tumors; 4) To evaluate the immunogenicity of KLT-1101 in patients with advanced solid tumors. 3. Exploratory objectives 1) To evaluate the anti-tumor efficacy of KLT-1101 in patients with advanced solid tumors. To explore the recommended clinical dose of KLT-1101.

Start Date02 Dec 2020

Sponsor / Collaborator

KANG LI TAI Pharmaceutical Co., Ltd.

ChiCTR2000036309

/ SuspendedPhase 1/2IIT

Phase Ib/II clinical study on safety, tolerability, pharmacokinetics, and preliminary efficacy evaluation of KLT-1101 in patients with advanced solid tumors

Start Date31 Aug 2020

Sponsor / Collaborator

First Affiliated Hospital Bengbu Medical College

100 Clinical Results associated with KLT-1101

100 Translational Medicine associated with KLT-1101

100 Patents (Medical) associated with KLT-1101

100 Deals associated with KLT-1101

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 2	China	KANGLITAI BIOMEDICAL (QINGDAO) CO., LTD	25 Dec 2023
Kaposi Sarcoma	Phase 2	China	KANG LI TAI Pharmaceutical Co., Ltd.	23 Nov 2022
Advanced Malignant Solid Neoplasm	Phase 2	China	KANG LI TAI Pharmaceutical Co., Ltd.	02 Dec 2020
Leukopenia	Phase 2	China	KANG LI TAI Pharmaceutical Co., Ltd.	02 Dec 2020
Thrombocytopenia	Phase 2	China	KANG LI TAI Pharmaceutical Co., Ltd.	02 Dec 2020

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