This phase I trial studies the side effects and best dose of SOR-C13 in treating patients with solid tumors that have spread to other places in the body (advanced) and does not respond to treatment. Drugs used in chemotherapy, such as SOR-C13, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

开始日期2019-07-29

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT01578564 / Completed临床1期

Phase I, Open-label, Dose Escalation Study to Assess Safety and Tolerability of SOR-C13 in Subjects With Advanced Solid Tumors Commonly Known to Express the TRPV6 Ion Channel

The purpose of this study is to determine the safety and tolerability of the drug SOR-C13 when given as an intravenous infusion in patients with ovarian cancer or other cancers known to over express the TRPV6 calcium channel.

开始日期2012-07-01

申办/合作机构

Soricimed Biopharma, Inc.

100 项与 SOR-C13 相关的临床结果

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100 项与 SOR-C13 相关的转化医学

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100 项与 SOR-C13 相关的专利（医药）

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项与 SOR-C13 相关的文献（医药）

2018-01-01·Journal of Cancer3区 · 医学

Inhibition of Transient Receptor Potential Vanilloid 6 channel, elevated in human ovarian cancers, reduces tumour growth in a xenograft model

3区 · 医学

ArticleOA

作者: Rice, Christopher ; Lutes, Tyler ; Davey, Michelle ; Stewart, John M ; Ilenchuk, T Toney ; Dugourd, Dominique ; Wang, Yuzhuo ; Xue, Hui ; MacCormack, Tyson J

Background: Transient Receptor Potential Vanilloid 6 (TRPV6), a non-voltage gated calcium channel, is implicated in malignancies and correlates with Gleason scores in prostate cancer and with poor prognosis in breast cancer. Data on the TRPV6 status of ovarian malignancies has not received significant attention. The effect of inhibiting TRPV6 activity on ovarian tumour growth has never been reported. Methods: We quantified TRPV6 mRNA and protein in biopsies of five types of ovarian cancer at different stages and grades by quantitative PCR and immunohistochemistry respectively. We verified the presence of TRPV6 in SKOV-3 cells and xenografts by Western Blotting. NOD/SCID mice bearing xenografted ovarian tumours derived from SKOV-3 were treated daily with TRPV6-antagonistic peptides (SOR-C13 and SOR-C27) at 400, 600 and 800 mg/kg delivered intraperitoneally (i.p.) over 12 days. Data from qPCR and tumour growth experiments were compared with a Student's t-test. Immunohistochemical ranking of staining were compared with Kruskall-Wallace one-way ANOVA and Dunn's Multiple Comparison post-test. Results: TRPV6 mRNA and protein are significantly elevated at all stages and grades of 5 ovarian cancer types over normal tissue. Overall qPCR log2 values (n, mean, ± SEM) for mRNA in tumour (n = 165, 5.06 ± 0.16) were greater (p < 0.05) than normal tissues (n = 26, 0.45 ± 0.41). All stages and grades included in the biopsy arrays were significantly greater than normal tissues. Immunohistochemical staining of TRPV6 was ranked >2 (faint in most cells) in 80.5% of tumours (123) while 92% of normal tissues (23) ranked ≤ 2. Daily i.p. injection with SOR-C13 (400, 600 and 800 mg/kg) over 12 days inhibits tumour growth (59%) at the highest dose compared to non-treated controls. SOR-C27 at 800 mg/kg SOR-C27 inhibited tumour growth 55% after 12 days. Results of daily and intermittent dosing (Days 1, 2, 3 and 8, 9, 10) with SOR-C13 were indistinguishable. Conclusion: TRPV6 mRNA and protein are elevated in biopsies of ovarian cancers compared to normal tissue. Inhibition of TRPV6 activity significantly reduces ovarian tumour growth providing evidence that TRPV6 is a feasible oncology target in ovarian cancers.

2017-06-01·Investigational new drugs

Erratum to: First-in-human phase I study of SOR-C13, a TRPV6 calcium channel inhibitor, in patients with advanced solid tumors

Article

作者: Welch, S ; Lutes, T ; Rice, C ; Stewart, J M ; Dugourd, D ; Piha-Paul, S ; Liu, L ; Subbiah, V ; Ilenchuk, T T ; Hirte, H ; Nemet, A ; Fu, S ; Fields, N ; Hong, D ; Gong, J

2017-06-01·Investigational new drugs3区 · 医学

First-in-human phase I study of SOR-C13, a TRPV6 calcium channel inhibitor, in patients with advanced solid tumors

3区 · 医学

Article

作者: Welch, S ; Lutes, T ; Rice, C ; Dugourd, D ; Stewart, J M ; Piha-Paul, S ; Liu, L ; Subbiah, V ; Ilenchuk, T T ; Hirte, H ; Nemet, A ; Fu, S ; Fields, N ; Gong, J ; Hong, D

Summary:

Introduction This was an open-label, dose escalation (3 + 3 design), Phase I study of SOR-C13 in patients with advanced tumors of epithelial origin. Primary objectives were to assess safety/tolerability and pharmacokinetics. Secondary goals were to assess pharmacodynamics and efficacy of SOR-C13. Methods SOR-C13 was administered IV QD on days 1–3 and 8–10 of a 21-day cycle. Doses were 2.75 and 5.5 mg/kg (20-min infusion) and 1.375, 2.75, 4.13 and 6.2 mg/kg (90-min infusion). Toxicity was assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose limiting toxicity (DLT) was assessed within the first treatment cycle. Tumors were evaluated, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after two cycles. Results Twenty-three patients were treated. No drug-related serious adverse events occurred. DLTs occurred in six patients: asymptomatic, drug-related, transient Grade 2 hypocalcemia (4 patients), and unrelated Grade 3 anemia and Grade 3 atrial fibrillation, 1 patient each. Calcium and vitamin D supplementation eliminated further Grade 2 hypocalcemia. One Grade 3 treatment emergent adverse event, urticaria, was definitely related to SOR-C13. Four possibly drug-related, Grade 3 events (alanine aminotransferase and aspartate aminotransferase elevation, headache, and hypokalemia) were observed. Of 22 evaluable patients, 54.5% showed stable disease ranging from 2.8 to 12.5 months. The best response was a 27% reduction in a pancreatic tumor with a 55% reduction in CA19–9 levels at 6.2 mg/kg. Conclusion SOR-C13 was safe and tolerated up to 6.2 mg/kg. The Maximal Tolerated Dose (MTD) was not established. Stable disease suggested antitumor activity.

项与 SOR-C13 相关的新闻（医药）

2022-12-13

·BioSpace

Soricimed Appoints Leading North American Cancer Researcher Dr. Siqing Fu to its Scientific Advisory Board

MONCTON, NB, Dec. 13, 2022 /CNW/ - Soricimed Biopharma Inc., ("Soricimed" or "the Company"), a clinical stage company focused on the development and commercialization of first-in-class targeted cancer therapeutics, has appointed Dr. Siqing Fu, a North American leader in cancer research, to its Scientific Advisory Board. "We are honoured to have Dr. Fu join our Scientific Advisory Board at this pivotal time for our company," said Robert Bruce, Chief Executive Officer of Soricimed. "He brings extensive experience to the research table including investigational cancer therapies – specifically in novel design for phase I and II clinical trials. Dr. Fu's expertise will help enhance the trajectory of our work as we look to continue to validate the efficacy of our targeting platform in treating solid tumour cancers." "I am pleased to be joining Soricimed as a scientific advisor," said Dr. Fu. "Their platform, and the emergence of TRPV6 as a target in the treatment of cancer, have significant potential in multiple oncology applications. The results to date for Soricimed's targeting platform are promising and show that it could be a game-changing frontline therapy for this difficult disease." Dr. Fu has over 20 years of experience in cancer research and is currently a professor in the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. His research interests include novel design for Phase I/II clinical trials and chemosensitization via biological targeting agents like epigenetic therapy as complementary medicine for cancer treatment. He received his MD from Tongji Medical University (Shanghai, China) and a Clinical Fellowship, Section of Hematology and Medical Oncology, from the University of Rochester in New York, United States. About Soricimed Biopharma Inc. Soricimed is a privately held clinical stage company focused primarily on the development of targeted, first-in-class cancer treatments. Soricimed was established following the discovery of a unique and proprietary family of paralytic and anti-cancer peptides. The Company is committed to translating this discovery into novel therapies that deliver powerful treatment options for those living with devastating conditions. Soricimed's clinical stage oncology drug candidate, SOR-C13, a targeted anti-cancer peptide, has been granted orphan drug status for the treatment of pancreatic and ovarian cancers by the U.S. Food and Drug Administration. In addition, a portfolio of targeted Peptide-drug Conjugates (PDCs) and Peptide Receptor Radionuclide Therapies (PRRTs) are in various stages of pre-clinical development. For more information, visit . For more information about Soricimed and/or this announcement, please contact: Media Relations: Nick Williams NATIONAL Public Relations nwilliams@national.ca 647-354-2478 Investor Relations: Stephen Kilmer President, Kilmer Lucas Inc. stephen@kilmerlucas.com 646-274-3580 SOURCE Soricimed Biopharma

临床1期高管变更孤儿药

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15366

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期癌症	临床1期	美国	Soricimed Biopharma, Inc.	2012-07-01
晚期癌症	临床1期	加拿大	Soricimed Biopharma, Inc.	2012-07-01
晚期恶性实体瘤	临床1期	美国	Soricimed Biopharma, Inc.	2012-07-01
晚期恶性实体瘤	临床1期	加拿大	Soricimed Biopharma, Inc.	2012-07-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01578564 (AACR2016)	临床1期	晚期恶性实体瘤	23	SOR-C13	鹹獵簾範觸築繭艱壓構(餘艱醖廠壓繭鹽艱襯窪) = 30% 鑰築網簾淵鏇餘鬱蓋選 (餘簾膚醖淵壓鹹製艱繭 ) 更多	积极	2016-07-15