[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of IMB071703 injection in patients with recurrent or metastatic advanced solid tumors.

主要目的：评估IMB071703注射液治疗复发或转移的晚期实体瘤受试者的安全性和耐受性，最大耐受剂量（MTD）和/或II期临床研究推荐剂量（RP2D）。次要目的：评估IMB071703注射液治疗复发或转移的晚期实体瘤受试者的药代动力学（PK）特征，免疫原性，初步抗肿瘤活性（RECIST v1.1）。探索性目的：评估IMB071703注射液治疗复发或转移的晚期实体瘤受试者的药效学（PD）特征，初步抗肿瘤活性（iRECIST）。

[Translation]

Primary objective: To evaluate the safety and tolerability of IMB071703 injection in patients with recurrent or metastatic advanced solid tumors, including the maximum tolerated dose (MTD) and/or the recommended dose for Phase II clinical trials (RP2D). Secondary objective: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity, and preliminary antitumor activity of IMB071703 injection in patients with recurrent or metastatic advanced solid tumors (RECIST v1.1). Exploratory objective: To evaluate the pharmacodynamic (PD) characteristics and preliminary antitumor activity of IMB071703 injection in patients with recurrent or metastatic advanced solid tumors (iRECIST).

Start Date25 Nov 2025

Sponsor / Collaborator

Beijng Immunoah Pharma Tech Co., Ltd

NCT06292858

/ Unknown statusPhase 1

A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Patients With Recurrent or Metastatic, Advanced Solid Tumors

A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors

Start Date24 Feb 2023

Sponsor / Collaborator

Beijng Immunoah Pharma Tech Co., Ltd

100 Clinical Results associated with IMB-071703

100 Translational Medicine associated with IMB-071703

100 Patents (Medical) associated with IMB-071703

100 Deals associated with IMB-071703

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	China	Beijng Immunoah Pharma Tech Co., Ltd	24 Feb 2023
Neoplasms	IND Approval	United States	Beijng Immunoah Pharma Tech Co., Ltd	22 Feb 2024

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