A Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients With Unresectable Locally Advanced Or Metastatic Solid Tumors

This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.

Start Date01 Sep 2023

Sponsor / Collaborator

Yingbairui (Hangzhou) Biomedical Co., Ltd.

CTR20231412 / RecruitingPhase 1

评价IBR854细胞注射液在不可切除的局部晚期或转移性实体肿瘤患者中的安全性、耐受性及初步疗效的I期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability and preliminary efficacy of IBR854 cell injection in patients with unresectable locally advanced or metastatic solid tumors

主要目的：评价IBR854细胞注射液的安全性和耐受性；确定IBR854细胞注射液推荐的II期剂量（RP2D）和/或最大耐受剂量（MTD）。次要目的：初步评价IBR854细胞注射液在不可切除的局部晚期或转移性实体瘤患者中的抗肿瘤疗效；描述IBR854细胞注射液的药代动力学（PK）特征；评估IBR854细胞注射液的免疫原性。探索性目的：探索IBR854中的自然杀伤细胞（NK）供者和受者人类白细胞抗原（HLA）及杀伤细胞免疫球蛋白样受体（KIR）匹配程度和疗效的关系；回顾性分析肿瘤抗原5T4表达情况和疗效的相关性。

[Translation]

Primary objectives: To evaluate the safety and tolerability of IBR854 cell injection; to determine the recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD) of IBR854 cell injection. Secondary objectives: To preliminarily evaluate the anti-tumor efficacy of IBR854 cell injection in patients with unresectable locally advanced or metastatic solid tumors; to describe the pharmacokinetic (PK) characteristics of IBR854 cell injection; and to evaluate the immunogenicity of IBR854 cell injection. Exploratory objectives: To explore the relationship between the matching degree of human leukocyte antigen (HLA) and killer cell immunoglobulin-like receptor (KIR) between natural killer cell (NK) donors and recipients in IBR854 and the efficacy; and to retrospectively analyze the correlation between the expression of tumor antigen 5T4 and the efficacy.

Start Date31 Aug 2023

Sponsor / Collaborator

Yingbairui (Hangzhou) Biomedical Co., Ltd.

NCT05137275 / RecruitingEarly Phase 1IIT

Dose Escalation and Extension Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Anti-5T4 CAR-raNK Cell Therapy in Locally Advanced or Metastatic Solid Tumors

This study is a multicenter, open-label, investigator-initiated trial (IIT), divided into dose escalation (Part A) and dose extension (Part B) phases to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacokinetics (PD) and initial efficacy of conjugated antibody redirecting ready-to-use allogeneic NK (CAR-raNK) cells that target trophoblast glycoprotein (5T4) in patients with locally advanced or metastatic solid tumors.

Start Date24 Nov 2021

Sponsor / Collaborator

Shanghai East Hospital

[+1]

100 Clinical Results associated with IBR854

100 Translational Medicine associated with IBR854

100 Patents (Medical) associated with IBR854

Literatures (Medical) associated with IBR854

21 Oct 2023·Pharmaceutical Development and Technology

Design of experiments approach on the compaction properties of co-amorphous tablets

Article

Author: Grohganz, Holger ; Buchart, Laura ; Engelsing, Florian

Co-amorphous systems are an evolving strategy to stabilize the amorphous form of a drug molecule with the aim of overcoming its poor water-solubility. With research focussing on the molecular level of co-amorphous systems, little is known about their downstream processing. In this study, tablets of co-amorphous carvedilol and aspartic acid (CAR-ASP) with calcium hydrogen phosphate and croscarmellose sodium as excipients were produced using a compaction simulator. The amorphous form of spray dried CAR-ASP and the subsequently produced tablets was confirmed with XRPD. Over the storage time of 12 weeks, no recrystallization of the amorphous material was observed. A central composite face-centred design with three factors was set up to investigate the interplay of formulation and processing variables with the tablet characteristics elastic work, tensile strength and disintegration time. As a result, increasing the amount of co-amorphous material led to a decrease in elastic work and an increased tensile strength. These effects were beneficial for tablet properties, namely harder tablets and reduced elasticity. Disintegration time was prolonged by amounts of up to 25-30% co-amorphous material, while larger amounts induced faster tablet disintegration. While showing the feasibility of compacting co-amorphous material with calcium hydrogen phosphate, this study also gives insight into how tablet characteristics are affected by co-amorphous material and relevant process parameters.

01 Jul 2022·Chemistry & Biodiversity

DPA‐Substituted Carbazole Derivative as a Fluorescent Ligand for G4 DNA

Article

Author: Zhang, Feng ; Wang, Ming‐Qi ; Luo, Yang ; Wang, Ming ; Shuo, Li

AbstractHerein a conjugated dipicolylamine/carbazole (Car‐DPA) molecule was designed and synthesized to enhance the performance for the application as a G4 fluorescent ligand. This ligand has been found to display distinct and specific fluorescence enhancements in the presence of various G4 DNA structures, but limited with ssDNA or dsDNAs. The detail binding characteristics of the ligand with c‐MYC G4 DNA were investigated by fluorescence, UV/VIS absorption, CD spectroscopy, and molecular docking. The present study demonstrated that Car‐DPA bound to c‐MYC G4s with a two‐step complex formation, in which the binding mode appeared to be end‐stacking. Confocal fluorescence images indicated that ligand Car‐DPA could locate in nucleus, which is quite prominent from the cellular internalization studies.

01 Aug 2021·International Journal of PharmaceuticsQ2 · MEDICINE

The influence of moisture on the storage stability of co-amorphous systems

Q2 · MEDICINE

Article

Author: Rades, Thomas ; Liu, Jingwen ; Grohganz, Holger

Co-amorphization has been utilized to improve the physical stability of the respective neat amorphous drugs. However, physical stability of co-amorphous systems is mostly investigated under dry conditions, leaving the potential influence of moisture on storage stability unclear. In this study, carvedilol-L-aspartic acid (CAR-ASP) co-amorphous systems at CAR to ASP molar ratios from 3:1 to 1:3 were investigated under non-dry conditions at two temperatures, i.e., 25 °C 55 %RH and 40 °C 55 %RH. Under these conditions, the highest physical stability of CAR-ASP systems was observed at the 1:1 M ratio. This finding differed from the optimal molar ratio previously obtained under dry conditions (CAR-ASP 1:1.5). Molecular interactions between CAR and ASP were affected by moisture, and salt disproportionation occurred during storage. Morphological differences of systems at different molar ratios could be observed already after one week of storage. Furthermore, variable temperature X-ray powder diffraction measurements showed that excess CAR or excess ASP, existing in the binary systems, resulted in a faster recrystallization compared to equimolar system. Overall, this study emphasizes the influence of moisture on co-amorphous systems during storage, and provides options to determine the optimal ratio of co-amorphous systems in presence of moisture at comparatively short storage times.

100 Deals associated with IBR854

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Malignant Solid Neoplasm	Phase 1	CN	Yingbairui (Hangzhou) Biomedical Co., Ltd.	01 Sep 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

IBR854

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation