Delving into the Latest Updates on TR-64 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Tarapeutics Science Inc

Active Organization

Tarapeutics Science Inc

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.

Start Date12 Jan 2023

Sponsor / Collaborator

Tarapeutics Science Inc

CTR20223152 / RecruitingPhase 1

在晚期恶性实体瘤患者中评价TR64片的安全性、耐受性和药代动力学特征的单臂、开放、剂量递增Ⅰ期临床试验

[Translation] A single-arm, open-label, dose-escalation phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of TR64 tablets in patients with advanced malignant solid tumors

主要研究目的：评价 TR64 片在晚期恶性实体瘤患者的安全性和耐受性，确定最大耐受剂量，并评价TR64 片单药口服治疗的剂量限制性毒性（DLT），初步确定推荐的Ⅱ期临床试验剂量（RP2D）。次要研究目的：评价 TR64 片单次和多次给药在晚期恶性实体瘤患者的人体药代动力学特征。探索性研究目的：记录并初步评价TR64 片的抗肿瘤疗效（ORR、PFS、DOR、DCR 和CBR）。

[Translation]

Main study objectives: To evaluate the safety and tolerability of TR64 tablets in patients with advanced malignant solid tumors, determine the maximum tolerated dose, and evaluate the dose-limiting toxicity (DLT) of TR64 tablets for oral treatment alone, and preliminarily determine the recommended Phase II clinical trial dose (RP2D). Secondary study objectives: To evaluate the pharmacokinetic characteristics of single and multiple doses of TR64 tablets in patients with advanced malignant solid tumors. Exploratory study objectives: To record and preliminarily evaluate the anti-tumor efficacy (ORR, PFS, DOR, DCR and CBR) of TR64 tablets.

Start Date04 Jan 2023

Sponsor / Collaborator

Tarapeutics Science Inc

100 Clinical Results associated with TR-64

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100 Translational Medicine associated with TR-64

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100 Patents (Medical) associated with TR-64

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100 Deals associated with TR-64

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