[Translation] A multicenter, open-label, Phase Ia/Ib clinical study of PTX-912 for injection in patients with locally advanced or metastatic solid tumors.

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.

ChiCTR2400093388

/ 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

Start Date01 Sep 2024

Sponsor / Collaborator

Shanghai East Hospital

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

100 Translational Medicine associated with PTX-912

100 Patents (Medical) associated with PTX-912

100 Deals associated with PTX-912

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 1	China	Bozhi Biotechnology (Shanghai) Co., Ltd.	26 Nov 2024
Advanced cancer	Phase 1	United States	Proviva Therapeutics, Inc.	11 Jun 2024
Locally Advanced Malignant Solid Neoplasm	Phase 1	United States	Proviva Therapeutics, Inc.	11 Jun 2024
Neoplasm Metastasis	Phase 1	United States	Proviva Therapeutics, Inc.	11 Jun 2024
Metastatic Solid Tumor	IND Approval	China	Bozhi Biotechnology (Shanghai) Co., Ltd.	12 Oct 2024

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