An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies.

This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer.

开始日期2023-03-01

申办/合作机构

Sorrento Therapeutics, Inc.

NCT04809012

/ Withdrawn临床2期

An Open-label, Multicenter, Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors

This study evaluates the efficacy of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected solid tumors.

开始日期2021-06-01

申办/合作机构

Sorrento Therapeutics, Inc.

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项与 Danburstotug 相关的文献（医药）

2021-12-01·Investigational new drugs3区 · 医学

A phase I study of IMC-001, a PD-L1 blocker, in patients with metastatic or locally advanced solid tumors

3区 · 医学

Article

作者: Oh, Do-Youn ; Kim, Tae Min ; Park, Young Suk ; Lee, Jeeyun ; Ahn, Yoen Hee ; Choi, Ji Yea ; Kim, Hyeon Ju ; Chang, Sook Kyung ; Kang, Won Ki ; Park, Jihyun ; Park, Yeon Hee ; Keam, Bhumsuk ; Lee, Ji Hye ; Ock, Chan-Young ; Song, Yun Jeong

Introduction IMC-001 is a fully human IgG1 monoclonal antibody that binds to human PD-L1 (programmed death-ligand 1). This study evaluated the safety, pharmacokinetics, and pharmacodynamics of IMC-001 in patients with advanced solid tumors. Materials and Methods This open-labeled phase I study used a standard 3 + 3 dose-escalation design, with doses ranging from 2 to 20 mg/kg. IMC-001 was administered intravenously every 2 weeks until disease progression or unacceptable toxicity. The dose-limiting toxicity window was defined as 21 days from the first dose. Results Fifteen subjects were included in 5 dose-escalation cohorts. No dose-limiting toxicity was observed, and the maximum tolerated dose was not reached. The most common adverse events (AEs) were general weakness, decreased appetite, fever, and cough. No grade 4 or 5 treatment emergent AEs were reported during the study. One subject in the 2 mg/kg cohort showed grade 2 immune-induced thyroiditis and diabetes mellitus suspected to be related to IMC-001. Over the dose range of 2-20 mg/kg IMC-001, the AUC_0-14d, AUC_0-∞, and C_max generally increased in a dose-proportional manner for each step of dose escalation. Of the 15 enrolled patients, 1 subject with rectal cancer showed a partial response, and the disease control rate was 33.3%. Conclusions IMC-001 demonstrated a favorable safety profile up to 20 mg/kg administered intravenously every 2 weeks and showed preliminary efficacy in patients with advanced solid tumors. Based on pharmacokinetic and pharmacodynamic data, 20 mg/kg was selected as the recommended phase II dose. Clinical trial identification NCT03644056 (date of registration: August 23, 2018).

Journal of pain research3区 · 医学

A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

3区 · 医学

ArticleOA

作者: Gendreau, R Michael ; Pridgen, William L ; Duffy, Carol ; Gendreau, Judy F

OBJECTIVE:

Infections and other stressors have been implicated in the development of fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.

METHODS:

A total of 143 fibromyalgia patients were enrolled at 12 sites in a 16-week, double-blinded, placebo-controlled proof-of-concept trial. Randomized patients received either IMC-1 or placebo in a 1:1 ratio. Outcome measures included a 24-hour recall pain Numerical Rating Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Patient's Global Impression of Change (PGIC) questionnaire, the Multidimensional Fatigue Inventory, the NIH Patient-Reported Outcomes Measurement Information System (PROMIS), and the Beck Depression Inventory-II conducted at baseline and weeks 6, 12, and 16 of the study.

RESULTS:

A significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo. PGIC response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning, as measured by the FIQ-R, was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory. The safety profile was encouraging. Despite the celecoxib component of IMC-1, gastrointestinal and nervous system treatment emergent adverse events were reported less frequently in the IMC-1 group, and study completion rates favored IMC-1 treatment.

CONCLUSION:

IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.

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2025-06-02

·PRNewswire

ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025

CHICAGO, June 2, 2025 /PRNewswire/ -- ImmuneOncia Therapeutics, Inc. (CEO Heung-Tae Kim) announced interim results today from the ongoing Phase 1b clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC). The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA. The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anemia was observed in 2 of 13 patients (15%), and 96% of adverse events were Grade 1–2, occurring primarily in the first treatment cycle. Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit. AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumor cell membranes, whereas no response was observed in those with low expression - a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response. Professor Jeong-Yong Hong of Samsung Medical Center commented, "The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives. A 30% response rate is particularly promising, especially when compared to the approximately 10% typically observed with current second-line therapies for HCC." CEO Heung-Tae Kim stated, "Two of the three partial responders were resistant to first-line immunotherapy, suggesting IMC-002 may offer a new path forward via macrophage-based innate immunity. We are confident that this combination could redefine second-line treatment for HCC and will enhance our patient selection strategy through AI-driven biomarker analysis." IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimize binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia. ImmuneOncia is currently conducting Phase 1b trial of IMC-002 in patients with solid tumors. In 2021, the company out-licensed the asset to China's 3D Medicines in a deal worth up to $470 million. Its pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202. Following its KOSDAQ listing in May 2025, ImmuneOncia aims to strengthen its global presence in immuno-oncology. About IMC-002 IMC-002 is a novel immune checkpoint inhibitor targeting CD47, a "don't eat me" signal expressed on cancer cells. By blocking the CD47/SIRPα interaction, IMC-002 enhances macrophage-mediated phagocytosis. It is engineered to deliver high efficacy while minimizing binding to red blood cells and avoiding hematologic toxicity. About ImmuneOncia Therapeutics, Inc. Founded in 2016, ImmuneOncia is a South Korean clinical-stage biotech company specializing in immuno-oncology. With expertise in antibody development and translational science, the company is advancing a pipeline of checkpoint inhibitors and bispecific antibodies to address unmet needs in cancer treatment. Media Contact Jiwon Heo ImmuneOncia Therapeutics, Inc. Email: [email protected] Website: SOURCE ImmuneOncia Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床1期临床结果ASCO会议

2025-05-30

·癌度

逆转不可手术肺癌，靶向药 + PD-1治疗让两位患者成功手术！

癌度医学临床招募资讯微信群（点击）确诊肺癌的时候一般要进行病理分期，通过PET-CT等最先进的影像学检查技术来判断是否可以进行手术。早期肺癌可以通过手术或根治性放疗来治愈，但是对于局部晚期肺癌往往是难以手术的，为了争取手术治疗的机会所以就有新辅助治疗，在手术之前使用化疗将肿瘤病灶缩小争取手术，目前会在新辅助化疗的基础上使用PD-1抑制剂，数据表明增加PD-1可以提升完整手术切除率。BRAF基因在非小细胞肺癌的突变频率不是很高，对于BRAF基因V600E突变一般使用达拉非尼联合曲美替尼双靶向药治疗，下面是两个最新报道的IIIB期肺癌，这两个患者都是BRAF基因V600E突变，他们通过使用达拉非尼、曲美替尼联合PD-1实现了病理降期转诊进行了手术，并且获得了完全病理缓解。我们一起看看这个给到大家什么启发。本文参考文献刊例示意图1、第一个治疗病例这是一名69岁的亚裔男性患者，2024年11月就诊于北京大学人民医院，PET-CT检查右肺下叶有一个1.7厘米✖️1.4厘米的肿块，伴随纵膈淋巴结和双侧肺门淋巴结转移，经支气管内超声引导活检进行的病理确定为肺腺癌。基因检测为BRAF基因的V600E突变，PD-L1表达的TPS评分为90%（强阳性）。由于患者强烈倾向于手术干预，所以开始接受2个周期的诱导性化疗联合PD-1治疗（培美曲塞、卡铂和特瑞普利单抗），治疗后病情稳定，肺部病灶稍微增大。由于出现四级免疫相关性肝炎，所以停止了PD-1药物治疗后选择接受达拉非尼联合曲美替尼治疗。1个月后的CT显示原发肿瘤和受累淋巴结明显消退，达到了部分缓解。对部分淋巴结活检的病理未发现恶性肿瘤细胞。在进行MDT会诊后开始了手术治疗，最终获得了R0切除，肺部病灶以及淋巴结都没有发现肿瘤残留。术后一个月的MRD（肿瘤微小病灶残留病检测）结果为阴性，目前患者处于积极监测状态。第一名患者的治疗路径2、第二个治疗病例第二名患者是一个58岁的女性非吸烟病人，2025年1月确诊为左上肺腺癌，病理分期为IIIB期。基因突变为BRAF基因V600E， PET-CT检查显示右上肺中央有一个病变，伴有阻塞性肺炎。双侧纵膈、肺门以及左锁骨上区均有示踪剂吸收阳性的淋巴结，PD-L1的TPS评分小于1%（阴性）。患者接受达拉非尼和曲美替尼治疗4个月后，再次进行的PET-CT显示肿瘤和淋巴结均显著消退，达到了部分缓解。为了进一步巩固疗效、最大限度提高病理缓解率，患者使用了化疗联合免疫疗法进行巩固肿瘤，具体用药为培美曲塞、卡铂和替雷利珠单抗。化疗联合PD-1治疗2个周期后发现肿瘤病灶进一步缩小，对部分淋巴结活检没发现肿瘤残留。MDT会诊后认为患者符合手术条件。第二个患者的治疗路径由于患者肺门周围粘连紧密、纤维化，所以胸腔镜手术改为了开胸手术，最后患者获得了R0切除。仅在原发肿瘤病灶内检测到少量残留癌细胞（不到10%）。淋巴结没有发现存活癌细胞，术后MRD检测为阴性，患者后面进行一年PD-1抑制剂的维持治疗。3、参考别人经验，争取更好的手术每一个患者都希望能完整地进行手术，手术之后不会复发。希望本文的这两个IIIB期肺癌的治疗经验给到大家参考。尤其是靶向药和化疗联合免疫的搭配组合，手术之前的淋巴结预防性检测，手术之后的MRD监控复发。尤其是靶向药与化疗联合免疫治疗的搭配，术前淋巴结监测及术后MRD监控复发，都是非常值得参考的治疗手段。上面两个患者的术前用药恰好相反，但是不管是先用化疗联合PD-1，还是先用双靶向药，只要是肿瘤病灶缩小，能实现降期并进行手术就是最好的治疗方案。欢迎大家关注癌度，加入癌度病友群，了解全球肿瘤诊疗的最新策略。（长按图片扫描二维码加癌度王博微信咨询）参考文献：S. Cheng, et al., Induction therapy with dabrafenib, trametinib, and PD-1 inhibitor and surgical conversion in unresectable stage III non-small cell lung cancers with BRAF V600E mutation: 2 cases, Lung Cancer (2025). 往期推荐 “靶向药 + 化疗”能延缓肺癌耐药，但能否延长患者寿命？最新研究揭秘！胃癌进展后无药可用？新型CAR-T疗法IMC 001让90%的患者病情得以控制，有患者争取到手术机会!突破！80%实体瘤存在同一靶点PRL3，国际二期试验公布抗癌新药数据解决奥希替尼多种耐药位点，第四代EGFR靶向药H002于美国和中国同时启动临床试验，专治C797S类耐药位点！

免疫疗法临床3期放射疗法临床结果

2023-10-23

·BioSpace

ImmuneOncia Announces Phase 1 Results of CD47 Antibody at ESMO 2023

SEOUL, South Korea--(BUSINESS WIRE)-- ImmuneOncia (CEO Heung Tae Kim) announced the results of its Phase 1a solid tumour clinical trial (IMC-002-K102 Study) of IMC-002, a CD47 monoclonal antibody, at the European Society for Medical Oncology (ESMO 2023) held in Madrid, Spain on October 23rd, 2023. The dose-escalation study aimed to assess the safety and tolerability, and to establish the recommended Phase 2 dose (RP2D) of IMC-002. From May 2022 to October 2023, a total of 12 patients were enrolled in four dose cohorts, each receiving IMC-002 at doses of 5, 10, 20, or 30 mg/kg every 2 weeks (Q2W). The clinical data showed no dose-limiting toxicities (DLT). 92% of treatment-related adverse events (TRAE) were of Grade 1-2, with 94% occurring during the first treatment cycle. Common side effects associated with anti-CD47 therapy, such as infusion-related reactions, thrombocytopenia, and neutropenia, were not reported. The recommended Phase 2 dose of 20 mg/kg every 3 weeks (Q3W) was established. 6 out of 11 evaluable patients with measurable lesions also demonstrated stable disease (SD). 5 of the patients had liver cancer, and 1 had breast cancer. Professor Ho Young Lim of Samsung Medical Center, the Principal Investigator (PI) of IMC-002, commented, "CD47 is a promising immune checkpoint inhibitor for activating the anticancer function of macrophages, but it is also expressed on normal cells, raising concerns about hemolytic anemia and thrombocytopenia. However, most of the side effects of IMC-002 were mild, and 4 out of 6 SD patients received long-term treatment for over 6 months. This clinical trial has confirmed the safety of IMC-002." Heung Tae Kim, CEO of ImmuneOncia, said, "The recommended dose of every 3 weeks (Q3W) enhances patient convenience and opens up combination treatment opportunities with immune checkpoint inhibitors such as PD-(L)1 or other cytotoxic agents. Observing disease control for over 6 months in 4 SD patients, we expect to further confirm efficacy in Phase 1b, which is set to commence in November this year. We hope to further advance towards our goal of providing patients with a best-in-class anti-CD47 therapy." IMC-002 is an anti-CD47 antibody that functions as an immune checkpoint inhibitor against macrophages, allowing them to attack cancer cells by blocking the 'don't eat me' signal between CD47 on cancer cells and SIRPα on macrophages. IMC-002 is expected to have a good safety pro minimising binding to normal cells, including red blood cells. ImmuneOncia is a biotechnology company specialising in immuno-oncology drug development. In addition to the CD47 antibody IMC-002, ImmuneOncia also has a wide range of pipeline that includes the Phase 2 clinical-stage PD-L1 antibody IMC-001, and the preclinical-stage bispecific antibody IMC-201.

免疫疗法临床1期临床结果临床2期

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适应症	最高研发状态	国家/地区	公司	日期
高肿瘤突变负荷肿瘤	临床2期	韩国	Immuneoncia Therapeutics, Inc.	2025-01-13
局部晚期恶性实体瘤	临床2期	韩国	Immuneoncia Therapeutics, Inc.	2025-01-13
胆管癌	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
弥漫性大B细胞淋巴瘤	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
胆囊肿瘤	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
肝内胆管癌	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
外周T细胞淋巴瘤	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
难治恶性实体肿瘤	临床2期	-	Sorrento Therapeutics, Inc.	2021-06-01
复发性实体肿瘤	临床2期	-	Sorrento Therapeutics, Inc.	2021-06-01
结外NK-T细胞淋巴瘤	临床2期	韩国	Immuneoncia Therapeutics, Inc.	2020-10-27

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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


NCT04414163 (DISTINKT Study, ICML2023)	临床2期	结外NK-T细胞淋巴瘤	15	IMC-001 20 mg/kg	窪鑰簾襯鹽網製選餘積(淵簾廠網鹽衊夢廠構蓋) = 鹽選遞構鬱齋壓糧醖鹽簾夢廠顧繭積簾積積窪 (襯餘製糧膚鑰廠憲夢顧 )	积极	2023-06-09
NCT04196465 (Neo-Chance, AACR2023) 人工标引	临床2期	胃肠道肿瘤辅助 Microsatellite Stable (MSS) \| PD-L1 Expression	50	IMC-001 20 mg/kg	餘艱範築積願廠夢範齋(衊顧齋範繭鏇醖醖夢窪) = Although there was no major pathologic response, 51% of pts showed various degree of tumor necrosis or fibrosis and 7 pts (15%) had residual viable tumor cells less than 50%. 鬱淵齋艱獵衊衊簾襯蓋 (齋鑰積衊鏇蓋衊鏇襯鑰 ) 更多	积极	2023-04-14
NCT04196465 (Neo-Chance, AACR2023) 人工标引	临床2期	胃肠道肿瘤辅助 Microsatellite Stable (MSS) \| PD-L1 Expression	50	IMC-001 20 mg/kg (metabolic response-evaluable pts)		积极	2023-04-14
NCT04414163 (ESMO_ASIA2022) 人工标引	临床2期	结外NK-T细胞淋巴瘤	13	IMC-001 20 mg/kg	顧膚鏇壓壓醖齋遞廠鬱(鑰壓衊積遞鬱膚鏇願範) = 願簾鑰構襯鹹醖齋衊鏇鏇壓製艱壓鹹顧憲鏇蓋 (範壓鹹鑰廠觸壓艱鹹鑰 ) 更多	积极	2022-12-04
NCT03644056 (Pubmed \| Invest New Drugs) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	15	IMC-001	鹹鑰觸遞繭繭積鬱獵糧(鹹廠遞構鏇襯顧顧築齋) = 鏇糧廠願鹹窪艱積蓋鹹齋繭醖獵獵遞蓋鏇築窪 (構鑰蓋鹽醖蓋膚鑰鹽積 ) 更多	积极	2021-12-01
NCT04196465 (NeoChance, ASCO2020)	临床2期	胃肠道肿瘤新辅助	14	IMC-001	鏇壓鬱淵願醖餘築淵鏇(鏇範齋獵鏇觸繭網獵餘) = 構鏇膚鹽醖願憲繭醖壓鏇衊網網憲齋膚窪憲齋 (壓鏇廠夢鹽鑰壓衊憲選 )	-	2020-05-25