A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients With Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC).

This is a Phase 1, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
IPM514 will be administered by intramuscular injection. Six ascending dose cohorts of IPM514 will be evaluated, with each cohort planned to enroll 3-6 qualified participants after a screening period of up to 28 days, following 3 + 3 study design format, the dose levels are as follows: 50 µg, 100 µg, 200 µg, 300 µg, 450 µg, and 600 µg. It may be adjusted during the dose escalation study based on the emerging data of safety, efficacy, and biological responses upon Safety Monitoring Committee (SMC) approval.

Start Date30 Jun 2026

Sponsor / Collaborator

Beijing Zhenzhi Medical Technology Co., Ltd.

NCT06690476

/ RecruitingEarly Phase 1IIT

A Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma

This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant therapy cohort(IPM514 combined with anti-PD-1 antibody, cisplatin and paclitaxel).The dose escalation and dose expansion stages will include patients with unresectable advanced, recurrent or metastatic ESCC who have failed first-line treatment. After confirming the preliminary safety and effectiveness in the dose escalation and dose expansion stages, a neoadjuvant therapy cohort study will be developed, and resectable ESCC subjects will be included.

Start Date10 Oct 2024

Sponsor / Collaborator

Peking University

CTR20254660

/ Not yet recruitingPhase 1

评价IPM514治疗晚期食管鳞状细胞癌的安全性、耐受性、药代动力学、药效学和初步临床疗效的开放、多中心1期临床研究

[Translation] An open-label, multicenter phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of IPM514 in the treatment of advanced esophageal squamous cell carcinoma.

主要目的：评价IPM514治疗不可切除的局部晚期或转移性食管鳞状细胞癌的安全性和耐受性；确定IPM514的MTD(如有)或2期研究推荐剂量（RP2D）；评价IPM514的药代动力学（PK）特征。次要目的：评估IPM514治疗不可切除的局部晚期或转移性食管鳞状细胞癌的初步临床有效性；评价IPM514的药效学特征；评价IPM514的免疫原性。探索性目的：探索与疗效相关的生物标志物，包括但不限于肿瘤组织抗原表达，PD-L1表达，微小残留病灶（MRD），血液检测的肿瘤突变负荷（bTMB）等。

[Translation]

Primary Objectives: To evaluate the safety and tolerability of IPM514 in treating unresectable locally advanced or metastatic esophageal squamous cell carcinoma; To determine the MTD (if applicable) or recommended dose (RP2D) for phase 2 studies of IPM514; To evaluate the pharmacokinetic (PK) characteristics of IPM514. Secondary Objectives: To assess the preliminary clinical efficacy of IPM514 in treating unresectable locally advanced or metastatic esophageal squamous cell carcinoma; To evaluate the pharmacodynamic characteristics of IPM514; To evaluate the immunogenicity of IPM514. Exploratory Objectives: To explore biomarkers related to efficacy, including but not limited to tumor tissue antigen expression, PD-L1 expression, minimal residual disease (MRD), and tumor mutational burden (bTMB) measured in blood.

Start Date-

Sponsor / Collaborator

Beijing Zhenzhi Medical Technology Co., Ltd.

100 Clinical Results associated with IPM-514

100 Translational Medicine associated with IPM-514

100 Patents (Medical) associated with IPM-514

100 Deals associated with IPM-514

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	Phase 1	-	Beijing Zhenzhi Medical Technology Co., Ltd.	30 Jun 2026
Advanced Esophageal Squamous Cell Carcinoma	Phase 1	China	Beijing Zhenzhi Medical Technology Co., Ltd.	25 Nov 2025

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