[Translation] A Phase Ib/II clinical study to evaluate the efficacy and safety of DX126-262 in the treatment of subjects with HER2-overexpressing, unresectable locally advanced or recurrent metastatic urothelial carcinoma.

一项评估DX126-262治疗HER2过表达不可切除的局部晚期或复发转移性尿路上皮癌受试者的有效性及安全性的Ib/Ⅱ期临床研究。

[Translation]

A Phase Ib/II clinical study to evaluate the efficacy and safety of DX126-262 in the treatment of subjects with HER2-overexpressing, unresectable locally advanced or recurrent metastatic urothelial carcinoma.

Start Date11 Aug 2022

Sponsor / Collaborator

Hangzhou DAC Biotechnology Co., Ltd.

CTR20220870 / RecruitingPhase 1/2

一项评估DX126-262在HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者中的安全性、有效性及药代动力学特征的Ib/II期临床研究

[Translation] A Phase Ib/II clinical study to evaluate the safety, efficacy and pharmacokinetics of DX126-262 in patients with HER2-overexpressing unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma)

Ib期：评价DX126-262 在HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者中的安全性和耐受性，确定Ⅱ期临床试验推荐剂量（RP2D）；评价DX126-262在HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者中的药代动力学（PK）特征；评价DX126-262对HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者产生的免疫原性；评价DX126-262在HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者中的初步疗效。 Ⅱ期：评价DX126-262在HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者中的疗效；评价DX126-262在HER2过表达的不可切除的局部晚期或转移性胃癌（包括胃食管交界腺癌）患者中的安全性。

[Translation]

Phase Ib: Evaluate the safety and tolerability of DX126-262 in patients with HER2-overexpressing unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) and determine the recommended dose (RP2D) for Phase II clinical trials; evaluate the pharmacokinetic (PK) characteristics of DX126-262 in patients with HER2-overexpressing unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma); evaluate the immunogenicity of DX126-262 in patients with HER2-overexpressing unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma); evaluate the preliminary efficacy of DX126-262 in patients with HER2-overexpressing unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma). Phase II: To evaluate the efficacy of DX126-262 in patients with unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 overexpression; To evaluate the safety of DX126-262 in patients with unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 overexpression.

Start Date04 Jul 2022

Sponsor / Collaborator

Hangzhou DAC Biotechnology Co., Ltd.

CTR20211871 / RecruitingPhase 2

一项评估重组人源化抗HER2单抗-Tub114偶联剂（DX126-262）在HER2阳性不可切除的局部晚期或复发转移性乳腺癌患者中的有效性及安全性的Ⅱ期临床研究

[Translation] A phase II clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Tub114 conjugate (DX126-262) in patients with HER2-positive unresectable locally advanced or recurrent metastatic breast cancer

评价DX126-262在HER2阳性不可切除的局部晚期或复发转移性乳腺癌患者三线及以上治疗中的初步疗效，确定疗效确证阶段的剂量；评估DX126-26262在HER2阳性不可切除的局部晚期或复发转移性乳腺癌患者三线及以上治疗中的疗效。

[Translation]

To evaluate the preliminary efficacy of DX126-262 in the third-line or higher treatment of patients with HER2-positive, unresectable locally advanced or recurrent metastatic breast cancer, and determine the dose in the efficacy confirmation stage; to evaluate the efficacy of DX126-26262 in the third-line or higher treatment of patients with HER2-positive, unresectable locally advanced or recurrent metastatic breast cancer.

Start Date05 Nov 2021

Sponsor / Collaborator

Hangzhou DAC Biotechnology Co., Ltd.

100 Clinical Results associated with DX126-262

100 Translational Medicine associated with DX126-262

100 Patents (Medical) associated with DX126-262

Literatures (Medical) associated with DX126-262

01 Jan 2022·International Journal of Biological MacromoleculesQ1 · CHEMISTRY

Purification, structural characterization and antioxidant activity of a new arabinogalactan from Dorema ammoniacum gum

Q1 · CHEMISTRY

Article

Author: Ahmadi, Elham ; Alilou, Mostafa ; Stuppner, Hermann ; Moridi Farimani, Mahdi ; Rezadoost, Hassan

Gum ammoniacum is a polymer obtained from Dorema ammoniacum and its medicinal use was already known to the ancient times. In this study, a new D. ammoniacum carbohydrate (DAC-1) with a molecular weight of 27.1 kDa was extracted by hot water and then purified on DEAE-52-cellulose and Sephadex G-100 columns. The structural features of DAC-1 were investigated by partial acid hydrolysis, fourier-transform infrared spectroscopy (FT-IR), methylation, gas chromatography-mass spectrometry (GC-MS), gas chromatography-flame ionization detection (GC-FID), and 1D and 2D nuclear magnetic resonance spectroscopy (1D & 2D NMR). The results indicated that DAC-1 was an arabinogalactan including galactose, arabinose, rhamnose, glucuronic acid and 4-O-methyl-β-d-glucopyranosyl uronic acid (meGlcpA) with a relative percentage of 44.63%, 23.30%, 13.46%. 12.47%, and 6.14%. The structure units of DAC-1 were elucidated as 3,1)-β-_D-Galp-(6 → 1)-β-_D-Galp-(3,6 → containing four branch chains of →1,6)-β-_D-Galp-(3 → 1)-α-_L-Araf-(5 → 1)-β-_D-GlcpA-(4 → 1)-α-_L-Rhap-T (two times), →1,6)-β-_D-Galp-(3→1)-β-_D-Galp-(3 → 1)-β-_D-Galp-(3 → 1)-β-_D-Galp-(3 → 1)-α-_L-Araf-T and →1,6)-β-_D-Galp-(3 → 1)-α-_L-Araf-(5 → 1)-β-_D-meGlcpA-T. X-ray diffraction (XRD) pattern indicated a semi-crystalline structure. Thermal behavior of the polysaccharide was evaluated by thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC) and revealed temperatures higher than 200 °C as dominant region of weight loss. DAC-1 showed acceptable antioxidant activity when analyzed by DPPH, ABTS, FRAP, and OH radical removal methods.

01 Jan 1998·International Journal of Radiation BiologyQ4 · MEDICINE

Uptake, toxicity and radiation effects of the boron compounds DAAC-1 and DAC-1 in cultured human glioma cells

Q4 · MEDICINE

Article

Author: J. Malmquist ; J. Pettersson ; J. Carlsson ; P. Olsson ; Jeffrey Coderre ; S. Sjöberg ; Nina Tilly ; M. Black ; J. Capala ; Michael Makar ; T. Hartman

PURPOSETo study the uptake, toxicity and radiation effects in vitro of a diol-amino acid-carborane (DAAC-1) and make comparisons with the previously studied diol-amine-carborane (DAC-1).MATERIALS AND METHODSToxicity and radiation effects were studied with clonogenic survival, uptake by measuring the cellular boron content and the subcellular distribution was investigated after organelle separation with centrifugation. The studied cell line was human glioma U343.RESULTSDAAC-1 showed an accumulation of 1-1.5 times, compared with the culture medium, and was non-toxic up to 47 microg boron/ml. The accumulation of DAC-1 was about 90 times, but toxic effects were detectable already at the concentration 5 microg boron/ml. None of the compounds was localized in the cell nucleus. Following irradiation with thermal neutrons, DAC-1 was about 2.5 times more effective than DAAC-1 and about 4.9 times more effective than neutrons alone, at the survival level 0.2. The dose modifying factors, when compared with the neutron beam alone, were for both DAAC-1 and DAC-1 about 1.5 and about 5 when compared with 60Co-gamma-radiation.CONCLUSIONSDAAC-1 was less toxic than DAC-1 but gave less accumulation of boron. Both substances gave significant boron-dependent cell inactivation when the test cells were exposed to thermal neutrons.

01 Jan 1996·Radiotherapy and OncologyQ2 · MEDICINE

In vitro determination of toxicity, binding, retention, subcellular distribution and biological efficacy of the boron neutron capture agent DAC-1

Q2 · MEDICINE

Article

Author: Michael Makar ; Pär Olsson ; Jeffrey Coderre ; Jean Pettersson ; Torbjörn Hartman ; Bengt Glimelius ; Stefan Sjöberg ; Jörgen Carlsson ; Jonas Malmquist ; Nina Tilly

In boron neutron capture therapy (BNCT), 10B is delivered selectively to the tumour cells and the nuclide then forms high-LET radiation (4He2+ and 7Li3+) upon neutron capture. Today much research is focused on development of a variety of boron compounds aimed for BNCT. The compounds must be thoroughly analysed in preclinical tests regarding basic characteristics such as binding and subcellular distribution to enable accurate estimations of dose-modifying factors. DAC-1,2-[2-(3-amino-propyl)-1,2-dicarba-closo-dodecaboran (12)-1-yl-methoxy]- 1,3-propanediol was synthesized at our laboratories and the human colon carcinoma cells LS-174T were used as an in vitro model. The boron compound showed a remarkable intracellular accumulation, 20-100 times higher than the boron content in the culture medium, in cultured cells and was not removed by extensive washes. Approximately half of the boron taken up also remained within the cells for at least 4 days. The DAC-1 compound alone was not toxic at boron concentrations below 2.5 micrograms B/g. The intracellular distribution of the boron compound was investigated by subcellular fractionation experiments and low pH treatments. It is possible that DAC-1 binds to some intracellular molecules or to membranes connected with organelles in the cytoplasm or even to the inside of the outer cell membrane. Another possibility is that the compound, due to the somewhat lipophilic properties, is embedded in the membranes. Thermal neutron irradiations were carried out at the Brookhaven Medical Research Reactor (BMRR). At a survival level of 0.1, DAC-1 + thermal neutrons were about 10.5 times more effective in cell inactivation than the thermal neutrons alone. Monte Carlo calculations gave a mean value of the 10B-dependent specific energy, the dose, of 0.22 Gy. The total physical dose during irradiation of DAC-1-containing cells with a neutron fluence of 0.18 x 10(12) n/cm2 was 0.39 Gy. The dose-modifying factor, at survival level 0.1, when comparing irradiation with thermal neutrons with and without DAC-1 was 3.4, while the dose-modifying factor when comparing neutron irradiations of cells with DAC-1 and irradiation of the cells with 60Co-gamma was 7.3. The results are encouraging and in vivo tests of tissue distributions and tumour uptake should now be carried out.

100 Deals associated with DX126-262

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 2	CN	Hangzhou DAC Biotechnology Co., Ltd.	29 Aug 2022
Transitional Cell Carcinoma	Phase 2	CN	Hangzhou DAC Biotechnology Co., Ltd.	11 Aug 2022
Gastroesophageal junction adenocarcinoma	Phase 2	CN	Hangzhou DAC Biotechnology Co., Ltd.	04 Jul 2022
HER2 Positive Breast Cancer	Phase 2	CN	Hangzhou DAC Biotechnology Co., Ltd.	05 Nov 2021
Breast Cancer	Phase 1	US	Hangzhou DAC Biotechnology Co., Ltd.	07 Mar 2022
Stomach Cancer	Phase 1	US	Hangzhou DAC Biotechnology Co., Ltd.	07 Mar 2022
HER2 Positive Solid Tumors	Phase 1	CN	Hangzhou DAC Biotechnology Co., Ltd.	19 Sep 2019
HER2-positive gastric cancer	Phase 1	CN	Hangzhou DAC Biotechnology Co., Ltd.	19 Sep 2019

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