Delving into the Latest Updates on PTX-912 with Synapse

Overview

Basic Info

Drug Type

Antibody fusion proteins

Synonyms

Target

IL-2R x PD-1

Mechanism

IL-2R agonists(Interleukin-2 receptor agonists), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced cancerSolid tumorLocally Advanced Malignant Solid Neoplasm+ [1]

Inactive Indication-

Originator Organization

Proviva Therapeutics, Inc.

Active Organization

Proviva Therapeutics, Inc.

Bozhi Biotechnology (Shanghai) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的： 1.评估PTX-912在局部晚期或转移性实体瘤患者中的安全性和耐受性。 2.通过剂量限制性毒性（DLT）评估确定最大耐受剂量（MTD）、最佳生物学剂量（OBD）和/或II期临床试验推荐剂量（RP2D）。次要目的： 1.评价PTX-912在局部晚期或转移性实体瘤患者中的药代动力学（Pharmacokinetics，PK）特征和免疫原性。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of PTX-912 in patients with locally advanced or metastatic solid tumors. 2. To determine the maximum tolerated dose (MTD), optimal biological dose (OBD) and/or recommended dose for Phase II clinical trials (RP2D) through dose-limiting toxicity (DLT) evaluation. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of PTX-912 in patients with locally advanced or metastatic solid tumors.

Start Date26 Nov 2024

Sponsor / Collaborator

Bozhi Biotechnology (Shanghai) Co., Ltd.

NCT06190886

/ RecruitingPhase 1

A First-in-human (FIH), Multicenter, Open-Label, Phase Ia (Dose Escalation)/Phase Ib (Dose Expansion) Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912.
Participants will be treated with PTX-912 via iv infusion, every 2 weeks until progression of disease, unacceptable toxicity, or 12 months of total study therapy.

Start Date11 Jun 2024

Sponsor / Collaborator

Proviva Therapeutics, Inc.

100 Clinical Results associated with PTX-912

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100 Translational Medicine associated with PTX-912

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100 Patents (Medical) associated with PTX-912

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100 Deals associated with PTX-912

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 1	US	Proviva Therapeutics, Inc.	11 Jun 2024
Solid tumor	Phase 1	US	Proviva Therapeutics, Inc.	11 Jun 2024
Locally Advanced Malignant Solid Neoplasm	IND Approval	CN	Bozhi Biotechnology (Shanghai) Co., Ltd.	12 Oct 2024
Metastatic Solid Tumor	IND Approval	CN	Bozhi Biotechnology (Shanghai) Co., Ltd.	12 Oct 2024