CRAF inhibitors(C-Raf kinase inhibitors), CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), DDR1 antagonists(Discoidin domain receptor 1 antagonists)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Apollomics, Inc. (United States)

Active Organization

Zhejiang Guankebochuang Biopharmaceutical Co., Ltd.

Inactive Organization

Zhejiang Crownmab Biotech Co. Ltd.

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Structure

Molecular FormulaC23H19ClF3N5O3

InChIKeyDJRJTXSOXZTTSQ-UHFFFAOYSA-N

CAS Registry1529765-42-1

Clinical Trials associated with APL-102

NCT05055518 / Unknown statusPhase 1

Phase I Study on Safety, Tolerance, and Pharmacokinetics of APL-102 Capsule in Patients With Advanced Solid Tumors

This study will evaluate the safety and tolerability of APL-102 Capsule and characterize the pharmacokinetic (PK) profile in advanced solid tumor patients.

Start Date02 Aug 2021

Sponsor / Collaborator

Apollomics, Inc. (United States)

[+1]

CTR20211072 / RecruitingPhase 1

APL-102胶囊治疗晚期实体瘤患者的安全性，耐受性及药代动力学的I期临床研究

[Translation] A Phase I clinical study on the safety, tolerability and pharmacokinetics of APL-102 capsules in patients with advanced solid tumors

主要目的：1、评价APL-102胶囊的单次给药及多次给药的安全性及耐受性；2、确定最大耐受剂量（MTD）及推荐的Ⅱ期研究剂量（RP2D）。次要目的： 1、研究APL-102在晚期实体瘤患者中的人体药代动力学（PK）特征；2、在晚期实体瘤患者中评价APL-102胶囊给药的初步抗肿瘤活性。探索性目的：评估受试者血液中的 VEGF-A，M-CSF，sVEGFR2及 CD14dim/CD16+ 单核细胞水平在接受 APL-102治疗前后的变化，探索生物标治疗前后的变化，探索生物标志物与APL-102疗效的潜在相关性。评估肿瘤组织中 CSF1R，CD68，CD163，CD16， DDR1，CD3，CD4，CD8等药效学靶点和潜在的生物标志与APL-102疗效的潜在联系。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of single and multiple administrations of APL-102 capsules; 2. To determine the maximum tolerated dose (MTD) and the recommended Phase II study dose (RP2D). Secondary objectives: 1. To study the human pharmacokinetic (PK) characteristics of APL-102 in patients with advanced solid tumors; 2. To evaluate the preliminary anti-tumor activity of APL-102 capsules in patients with advanced solid tumors. Exploratory objectives: To evaluate the changes in VEGF-A, M-CSF, sVEGFR2 and CD14dim/CD16+ monocyte levels in the blood of subjects before and after APL-102 treatment, explore the changes in biomarkers before and after treatment, and explore the potential correlation between biomarkers and the efficacy of APL-102. Evaluate the potential relationship between pharmacodynamic targets and potential biomarkers such as CSF1R, CD68, CD163, CD16, DDR1, CD3, CD4, CD8 in tumor tissues and the efficacy of APL-102.

Start Date21 Jul 2021

Sponsor / Collaborator

Zhejiang Guankebochuang Biopharmaceutical Co., Ltd.

100 Clinical Results associated with APL-102

100 Translational Medicine associated with APL-102

100 Patents (Medical) associated with APL-102

100 Deals associated with APL-102

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Zhejiang Guankebochuang Biopharmaceutical Co., Ltd.	21 Jul 2021
Solid tumor	Phase 1	CN	Zhejiang Crownmab Biotech Co. Ltd.	21 May 2021

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