An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC.
ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

开始日期2025-02-20

申办/合作机构

AbbVie, Inc.

NCT06632951

/ Recruiting临床2期

A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma

Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide.
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

开始日期2025-01-20

申办/合作机构

AbbVie, Inc.

NCT06628310

/ Recruiting临床2期

A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor (Budigalimab) (AFLB) to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA).
ABBV-400 and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive fluorouracil, leucovorin, and oxaliplatin (FOLFOX). A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400The study will run for a duration of approximately 6 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

开始日期2024-12-13

申办/合作机构

AbbVie, Inc.

100 项与布格利单抗相关的临床结果

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100 项与布格利单抗相关的转化医学

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100 项与布格利单抗相关的专利（医药）

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项与布格利单抗相关的文献（医药）

2022-10-01·Annals of oncology : official journal of the European Society for Medical Oncology

Circulating L-arginine predicts the survival of cancer patients treated with immune checkpoint inhibitors

Article

作者: Chaput, N ; Le Loarer, F ; Tselikas, L ; Fontan, L ; Besse, B ; Roubaud, G ; Peyraud, F ; Cabart, M ; Auzanneau, C ; Italiano, A ; Barlesi, F ; Cousin, S ; Danlos, F-X ; Bodet, D ; Soria, J-C ; Nafia, I ; Bessede, A ; Guégan, J-P ; Planchard, D ; Even, C ; Marabelle, A ; Khettab, M ; Chomy, F

BACKGROUND:

The discovery of immune checkpoint inhibitors (ICIs) has revolutionized the systemic approach to cancer treatment. Most patients receiving ICIs, however, do not derive benefits. Therefore, it is crucial to identify reliable predictive biomarkers of response to ICIs. One important pathway in regulating immune cell reactivity is L-arginine (ARG) metabolism, essential to T-cell activation. We therefore aimed to evaluate the association between baseline plasma ARG levels and the clinical benefit of ICIs.

PATIENTS AND METHODS:

The correlation between ARG levels and clinical ICI activity was assessed by analyzing plasma samples obtained before treatment onset in two independent cohorts of patients with advanced cancer included in two institutional molecular profiling programs (BIP, NCT02534649, n = 77; PREMIS, NCT03984318, n = 296) and from patients in a phase 1 first-in-human study of budigalimab monotherapy (NCT03000257). Additionally, the correlation between ARG levels and ICI efficacy in preclinical settings was evaluated using a syngeneic mouse model of colorectal cancer responsive to ICIs. Using matched peripheral blood mononuclear cell (PBMC) plasma samples, we analyzed the correlation between ARG levels and PBMC features through multiplexed flow cytometry analysis.

RESULTS:

In both discovery and validation cohorts, low ARG levels at baseline (<42 μM) were significantly and independently associated with a worse clinical benefit rate, progression-free survival, and overall survival. Moreover, at the preclinical level, the tumor rejection rate was significantly higher in mice with high baseline ARG levels than in those with low ARG levels (85.7% versus 23.8%; P = 0.004). Finally, PBMC immunophenotyping showed that low ARG levels were significantly associated with increased programmed death-ligand 1 expression in several immune cell subsets from the myeloid lineage.

CONCLUSIONS:

We demonstrate that baseline ARG levels predict ICI response. Plasma ARG quantification may therefore represent an attractive biomarker to tailor novel therapeutic regimens targeting the ARG pathway in combination with ICIs.

2022-04-01·Journal of immunotherapy (Hagerstown, Md. : 1997)4区 · 医学

Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab

4区 · 医学

Article

作者: Tribouley, Catherine ; McLaughlin, Robert Tyler ; Masica, David L. ; Sheridan, James ; Vosganian, Greg ; Englert, Stefan ; Turan, Tolga ; Guo, Claire ; Afar, Daniel ; Zhang, Chun ; Lambert, Stacie L. ; Fang, Yuni

Budigalimab, a novel anti–PD-1 monoclonal antibody, demonstrated efficacy and biomarker pharmacodynamics in patients with head and neck squamous cell carcinoma (HNSCC) or non–small cell lung cancer (NSCLC) consistent with those reported by other PD-1 inhibitors. Herein are presented additional outcomes of biomarker analyses from the phase 1 study of budigalimab monotherapy in patients with HNSCC and NSCLC (NCT03000257). PD-1 inhibitor naive patients with advanced HNSCC (n=41) or NSCLC (n=40) received budigalimab intravenously at 250 mg every 2 weeks (Q2W) or 500 mg Q4W until progression. Archival tumor specimens were evaluated by immunohistochemistry for CD8 and tumor PD-1 ligand 1 (PD-L1) expression, RNA, and whole-exome sequencing. Serum and whole blood samples were acquired at baseline and at select on-treatment time points. As of October 2019, best overall response of 15% in HNSCC and 18% in NSCLC was observed in all treated patients; both cohorts reported responses in PD-L1+ and PD-L1– tumors. Treatment with budigalimab was associated with increases in multiple soluble biomarkers including interferon gamma-induced chemokines. Expanded overall T-cell counts, total CD8 T-cell counts, and percentages of CD8+CD45RA–CD62L– effector memory T cells were observed at cycle 1, day 15 in responders. Univariate analysis demonstrated an association between prolonged progression-free survival and higher tumor mutational burden/neoantigen load, smaller tumor size, lower platelet-lymphocyte ratios, lower CCL23, lower colony-stimulating factor 1, and lower interleukin-6 levels at baseline. The biomarker analysis presented herein identified additional early pharmacodynamic biomarkers associated with anti–PD-1 activity and improved clinical responses to budigalimab in patients with advanced HNSCC and NSCLC.

2022-02-01·Cancer immunology, immunotherapy : CII2区 · 医学

First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma

2区 · 医学

Article

作者: Warburton, Lydia ; Englert, Stefan ; Shiah, Her-Shyong ; Gazzah, Anas ; Lin, Chia-Chi ; Parikh, Apurvasena ; Afar, Daniel E ; Cassier, Philippe A ; Moreno, Victor ; Gao, Bo ; Vosganian, Gregory ; Calvo, Emiliano ; Cervantes, Andrés ; Tanner, Minna ; Alanko, Tuomo ; Italiano, Antoine ; Lambert, Stacie ; Peltola, Katriina J ; Tosi, Diego ; Roda, Desamparados ; Millward, Michael

Abstract:

Background:

Budigalimab is a humanized, recombinant immunoglobulin G1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) expansion cohorts of the phase 1 first-in-human study of budigalimab monotherapy (NCT03000257; registered 15 December 2016).

Patients and methods:

Patients with recurrent/metastatic HNSCC or locally advanced/metastatic NSCLC naive to PD-1/PD-1-ligand inhibitors were enrolled; patients were not selected on the basis of oncogene driver mutations or PD-L1 status. Budigalimab was administered at 250 mg intravenously Q2W or 500 mg intravenously Q4W until disease progression/unacceptable toxicity. The primary endpoints were safety and PK; the secondary endpoint was efficacy. Exploratory endpoints included biomarker assessments.

Results:

In total, 81 patients were enrolled (HNSCC: N = 41 [PD-L1 positive: n = 19]; NSCLC: N = 40 [PD-L1 positive: n = 16]); median treatment duration was 72 days (range, 1–617) and 71 days (range, 1–490) for the HNSCC and NSCLC cohorts, respectively. The most frequent grade ≥ 3 treatment-emergent adverse event was anemia (HNSCC: n = 9, 22%; NSCLC: n = 5, 13%). Both dosing regimens had comparable drug exposure and increased interferon gamma-induced chemokines, monokine induced by gamma interferon, and interferon-gamma-inducible protein 10. Objective response rates were 13% (90% CI, 5.1–24.5) in the HNSCC cohort and 19% (90% CI, 9.2–32.6) in the NSCLC cohort. Median progression-free survival was 3.6 months (95% CI, 1.7–4.7) and 1.9 months (95% CI, 1.7–3.7) in the HNSCC and NSCLC cohorts.

Conclusions:

The safety, efficacy and biomarker profiles of budigalimab are similar to other PD-1 inhibitors. Development of budigalimab in combination with novel anticancer agents is ongoing.

项与布格利单抗相关的新闻（医药）

2025-01-15

·SYNAPSE

2025年1月15日全球新药进展早知道

1. 智翔金泰狂犬病病毒双特异抗体申报上市 1月14日，CDE官网显示，智翔金泰瑞的斯乐韦米单抗注射液（GR1801）上市申请已获受理，用于成人疑似狂犬病病毒暴露后的被动免疫。斯乐韦米单抗是全球首个用于狂犬病被动免疫的双特异性抗体，由智翔金泰自主研发，作用靶点为RABV的包膜糖蛋白（Glycoprotein，G蛋白）。该药为scFv+Fab结构的双特异性抗体，使用KIH技术解决重链错配问题，使用scFv融合技术解决轻链错配问题，通过靶向结合G蛋白表位I和/或III，阻断其与受体的结合，在狂犬疫苗主动免疫完全发挥保护作用前阻滞病毒对神经的侵染，预防狂犬病。截至目前，国内仅有2款抗狂犬病病毒抗体药物获批上市。 2. 乐普生物溶瘤病毒拟纳入突破性治疗 1 月 14 日，CDE 官网显示，乐普生物递交的 CG0070 注射液拟纳入突破性治疗，适应症为对卡介苗（BCG）无应答的高危非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS）患者。CG0070（Cretostimogene Grenadenorepvec）是 CG Oncology 公司开发的一款具有双重作用机制的溶瘤病毒免疫疗法，靶向 Rb-E2F 通路，可选择性复制、裂解癌细胞并刺激免疫反应。乐普生物拥有 CG0070 在中国内地、香港、澳门地区的开发、制造和商业化权益。 3. 艾伯维c-MET ADC启动肺癌二线联合治疗临床 1月13日，艾伯维在clinical trials网站上，登记了下一代c-Met ADC药物Telisotuzumab Adizutecan 联合PD-1抗体 Budigalimab 二线治疗转移性鳞状非小细胞肺癌的1/2期临床试验NCT06772623，该临床预计于2025年2月底启动，入组人数为172例。此前于2024年9月27日，艾伯维宣布已向FDA递交c-Met靶向ADC药物telisotuzumab vedotin（Teliso-V，ABBV-399）的生物制品许可申请（BLA），用于治疗既往接受过治疗的c-Met蛋白过表达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺癌（NSCLC）成人患者。 4. 再生元PD-1抑制剂辅助治疗高危皮肤鳞状细胞癌显著提升无病生存期 1月13日，再生元制药宣布了3期C-POST试验的积极结果。该试验表明，PD-1抑制剂Libtayo®（cemiplimab）辅助治疗，能显著提高高危皮肤鳞状细胞癌（CSCC）患者术后的无病生存期（DFS），这一成果为这类患者的治疗带来了新希望。在首次预设的中期分析中，与安慰剂相比，接受Libtayo®治疗的患者疾病复发或死亡风险降低了68%（风险比：0.32；95%置信区间：0.20 - 0.51；$p<0.0001$）。这使得Libtayo®成为首个在辅助治疗高危CSCC中，展现出具有统计学意义和临床意义疗效的免疫疗法，而近期Keytruda®在相同辅助治疗场景下的3期试验却未能成功。 5. 绿叶制药新一代抗精神病药物在美国获准开展临床试验 1月14日，绿叶制药集团宣布，其自主开发的新一代抗精神病药物LY03020已获得美国食品药品监督管理局（FDA）许可开展临床试验，拟用于治疗精神分裂症。LY03020基于绿叶制药新分子实体/新治疗实体技术平台开发，是全球首个痕量胺相关受体1（TAAR1）和5-羟色胺2C受体（5-HT2CR）双靶点激动剂。临床前研究已表明，LY03020可显著改善精神分裂症阳性、阴性症状和认知障碍，且未见明显的EPS和体重增加、糖脂代谢异常等代谢综合征风险。LY03020亦在中国进入临床阶段。 1. 礼来25亿美元收购Scorpion，获得小分子PI3Kα抑制剂 1月13日，礼来公司和开Scorpion Therapeutics宣布，礼来公司将收购Scorpion的小分子PI3Kα抑制剂项目STX-478。STX-478是一种每日一次的口服突变选择性PI3Kα抑制剂，目前正在乳腺癌症和其他晚期实体瘤的1/2期临床试验中进行评估。根据协议条款，礼来将收购Scorpion，Scorpion股东将获得高达25亿美元的现金，包括预付款和在达到某些监管和销售里程碑后的后续付款。此外，作为交易的一部分，Scorpion将剥离一个新实体，以拥有其员工和非PI3Kα管线资产。 2. 吉利德17亿美元合作开发STAT6小分子疗法 1月13日，吉利德与LEO Pharma日前宣布达成战略合作伙伴关系，共同加速LEO Pharma的小分子口服STAT6项目的开发和商业化，旨在为炎症性疾病患者提供潜在治疗方案。根据该合作协议，吉利德将收购LEO Pharma的全部口服STAT6小分子抑制剂和靶向蛋白降解剂项目。吉利德将拥有开发、生产和商业化小分子口服STAT6项目的全球权利。LEO Pharma将有权选择在美国以外地区的皮肤病领域共同商业化口服项目。LEO Pharma将有资格获得总计高达17亿美元的款项，其中包括2.5亿美元的预付款。内容来源于网络，如有侵权，请联系删除。

小分子药物并购突破性疗法申请上市临床研究

2024-09-16

·PRNewswire

Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients

Results presented at ESMO Congress 2024 SOUTH SAN FRANCISCO, Calif., Sept. 16, 2024 /PRNewswire/ -- Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, today reported final results from a Phase 1 trial of TTX-030, a potential first-in-class, anti-CD39 antibody, in patients with first-line metastatic pancreatic cancer. Results were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. "The Phase 1 results demonstrated a strong median overall survival in patients with metastatic pancreatic cancer following treatment with TTX-030 combinations as well as marked benefit in those with high levels of tumor HLA-DQ biomarker expression," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "These findings have led to our currently enrolling global, randomized Phase 2 ELTIVATE study with results expected in 2026." The Phase 1 trial evaluated TTX-030 in combination with gemcitabine/nab-paclitaxel, with or without budigalimab (an investigational anti-PD-1 antibody), as first-line treatment for pancreatic adenocarcinoma. In the efficacy-evaluable population (n=57) consisting of 92% first-line metastatic and 8% locally advanced nonresecetable patients, the objective response rate (ORR) was 30%, with 3 complete responses; the median progression free survival (mPFS) was 7.5 months (95%CI 5.2, 9.4); and median overall survival was 19.1 months (9.8, NR). Analysis of pre-treatment tumor biopsies identified a subset of patients with a high expression of an immune-associated biomarker, HLA-DQ (HLA-DQhigh) and favorable clinical outcomes with TTX-030 combinations. Of the 28 HLA-DQhigh patients, the ORR was 46%, mPFS was 9.6 months (95% CI 3.9, 11.8), and mOS of 21.9 months (9.8, NR). Both treatment combinations were well-tolerated, with only five patients (8%) discontinuing treatment due to adverse events (AEs). The most frequent AEs were those expected from the standard of care chemotherapy backbone without an increase in frequency or severity. "Prior evaluation of immune checkpoint treatment has demonstrated limited benefit in this patient population and new approaches are needed. These results are very encouraging, especially in the biomarker high patients and warrant further investigation of TTX-030 for patients with advanced pancreatic cancer," said Zev Wainberg, MD, Professor of Medicine, UCLA. TTX-030 is currently being evaluated as first-line treatment for metastatic pancreatic adenocarcinoma in the global Phase 2 ELTIVATE trial (NCT06119217) that is randomizing approximately 180 patients into three study arms: TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 plus budigalimab and chemotherapy; or chemotherapy alone. The primary endpoint of the trial is progression-free survival (PFS) in a biomarker-enriched (HLA-DQhigh) population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link). About TTX-030 TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity. Trishula is continuing to develop TTX-030 in collaboration with AbbVie Inc. About Trishula Trishula is a privately held biotechnology company dedicated to the development of TTX-030. For more information, please visit . Media Contact: Julie Rathbun Rathbun Communications [email protected] 206-769-9219 SOURCE Trishula Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期临床1期免疫疗法

2024-07-29

·医药观澜

艾伯维抗艾滋病1类新药在中国获批临床

7月29日，中国国家药监局药品审评中心（CDE）官网公示，艾伯维（AbbVie）1类新药ABBV-382注射液获批临床，拟开发用于在不联合抗逆转录病毒疗法（ART）的情况下持续抑制免疫介导的HIV（HIV血浆病毒载量处于不可检出的水平）。公开资料显示，ABBV-382是一种α4β7整合素单克隆抗体，全球处于2期临床阶段，此次是这款在研新药在中国首次获批临床。截图来源：CDE官网 α4β7整合素在HIV-1感染的发病机制中起重要作用，这是一种异二聚体受体，在不同的免疫细胞上表达。α4β7在外周血CD4+T细胞中的表达可预测HIV-1获得和疾病进展。研究发现，α4β7存在于HIV-1病毒粒子的包膜上，这表明α4β7可能是HIV-1治疗的一个高度保守的靶点。公开资料显示，ABBV-382可通过直接拮抗α4β7与其同源配体MAdCAM-1或HIV-1 gp120的相互作用，从而抑制HIV-1复制/细胞间传播。此外，ABBV-382还能结合HIV-1病毒粒子中的α4β7形成免疫复合物（ICs）。这些ICs可以结合抗原呈递细胞上表达的fcgr，增强病毒抗原向T细胞的呈递，通过直接拮抗α4β7与其同源配体MAdCAM-1或HIV-1 gp120的相互作用，潜在地诱导免疫反应来控制病毒复制/细胞间传播。临床前研究结果表明，ABBV-382表现出良好的生物学特性和新的机制特性，支持其作为HIV-1病毒控制的基于免疫的干预措施。根据艾伯维官网，该公司正在开发ABBV-181 (budigalimab，抗PD-1）和ABBV-382的组合（研发代号：ABBV-1882），正在研究作为一种抗逆转录病毒治疗(ART)的HIV病毒控制方案，目前处于2期临床阶段。艾滋病是由于HIV感染引起的严重疾病，HIV主要有两种亚型，即HIV-1和HIV-2。相对来讲，HIV-1的复制能力更强，感染传播几率更高。HIV感染人体后，会侵犯免疫系统，包括CD4+T淋巴细胞、单核巨噬细胞和树突状细胞等，主要表现为CD4+T淋巴细胞数量不断减少，最终导致人体细胞免疫功能缺陷，引起各种机会性感染和肿瘤的发生。艾滋病曾经被认为是无药可治的致命疾病。随着上世纪末鸡尾酒疗法的建立，艾滋病已经成为可控的慢性疾病。尽管目前的疗法还不能够完全治愈HIV感染，但可以显著降低患者体内病毒数量，维持患者免疫功能，并且防止HIV病毒传播患者能够达到与普通人相当的预期寿命。参考资料： [1]中国国家药监局药品审评中心（CDE）官网.Retrieved Jul 29，2024,from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d [2] ABBV-382, an Anti-α4β7 Ab That Enhances HIV-1 Antigen Presentation for Immune-Mediated Viral Control.Retrieved Jul 29,2024,from https://www.croiconference.org/abstract/abbv-382-an-anti-%ce%b14%ce%b27-ab-that-enhances-hiv-1-antigen-presentation-for-immune-mediated-viral-control/ 内容来源于网络，如有侵权，请联系删除。

临床1期免疫疗法

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外链

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	临床3期	美国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	日本	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	澳大利亚	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	智利	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	以色列	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	波多黎各	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	中国台湾	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	土耳其	AbbVie, Inc.	2024-04-10
肝细胞癌	临床3期	美国	AbbVie, Inc.	2024-01-11
肝细胞癌	临床3期	法国	AbbVie, Inc.	2024-01-11

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临床结果

适应症

分期

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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


NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	临床1期	晚期恶性实体瘤 GARP:TGF-ß1 complex	-	Livmoniplimab	齋鬱製鹽鑰廠簾選鏇鹽(鹹醖願顧觸壓窪鹹網膚) = 衊遞構鬱夢繭築鏇衊顧鑰膚鹽齋鹹積壓淵鹹鹹 (構淵構夢繭夢壓簾築膚 )	积极	2024-10-29
				Budigalimab	觸壓醖鏇網積遞築糧鹽(艱膚糧顧齋築窪鹽構餘) = 淵網糧艱糧鬱艱夢築製顧鹽鏇遞鏇齋觸築衊憲 (築鬱選廠願餘窪繭鬱觸 ) 更多
NCT03821935 (ASCO2024)	临床1期	实体瘤 \| 尿路上皮癌 TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	鏇夢憲廠膚鑰廠壓鹹餘(艱醖餘遞艱獵積願鏇糧) = 鏇鏇積廠餘繭鑰襯網範淵鏇網選築積鏇積鏇淵 (積構鏇鏇鬱壓製網築製, 12.9 ~ 39.5) 更多	积极	2024-05-24
NCT03821935 (ASCO_GU2024) 人工标引	临床1期	尿路上皮癌	48	Livmoniplimab + budigalimab	糧醖膚獵鬱鏇窪餘願壓(糧糧範夢顧鏇鏇選齋淵) = 繭憲鏇艱觸鑰積鹽艱襯鑰餘膚廠夢衊窪鏇繭壓 (糧淵積壓選鹹觸簾範鹹, 12.9 ~ 39.5) 更多	积极	2024-01-25
NCT03000257 (Pubmed \| Cancer Immunol Immunother)	临床1期	头颈部鳞状细胞癌 \| 非小细胞肺癌	81	Budigalimab 250 mg	膚蓋艱壓築構顧窪獵鬱(淵壓糧膚獵襯顧構鑰遞) = 網衊願遞積鏇鏇淵範顧獵餘製衊廠鹽願襯築糧 (繭願醖鏇艱範醖構簾淵, 5.1 ~ 24.5)	-	2021-07-03
				Budigalimab 500 mg	膚蓋艱壓築構顧窪獵鬱(淵壓糧膚獵襯顧構鑰遞) = 糧鬱構憲鬱願構鬱齋糧獵餘製衊廠鹽願襯築糧 (繭願醖鏇艱範醖構簾淵, 9.2 ~ 32.6)
NCT03000257 (M15-892, Pubmed) 人工标引	临床1期	小细胞肺癌	31	rovalpituzumab tesirine+budigalimab	鹽艱齋艱膚顧獵築範窪(壓糧獵構構夢夢糧壓築) = 襯襯遞鑰衊衊遞壓繭選獵鹽餘選鏇齋壓壓廠餘 (淵壓遞鬱網廠衊齋鏇鹽 ) 更多	积极	2021-01-01
NCT03000257 (AACR2020)	临床1期	HR阳性/HER2低表达实体瘤	81	Budigalimab IV 250 mg every two weeks	鏇艱鏇壓齋選選簾憲壓(願糧網齋糧膚顧顧鏇廠) = 窪觸選鑰構衊積衊簾鹽餘願製衊廠鏇網醖壓繭 (鑰淵遞鑰鏇夢鏇積膚積 )	-	2020-08-15
				Budigalimab IV 500 mg every four weeks	鏇艱鏇壓齋選選簾憲壓(願糧網齋糧膚顧顧鏇廠) = 餘築窪簾廠衊鹽齋鹽艱餘願製衊廠鏇網醖壓繭 (鑰淵遞鑰鏇夢鏇積膚積 )
NCT03000257 (M15-891, SITC2018)	临床1期	晚期恶性实体瘤	62	ABBV-181 1 mg/kg	蓋鹽積範廠憲網淵壓積(鑰廠壓網鏇襯範壓築膚) = 憲鹹夢顧憲顧積製鑰鑰膚窪鹽夢遞繭蓋築淵遞 (遞選蓋鏇鹽壓艱顧窪範, 31 ~ 59) 更多	积极	2018-11-06
				ABBV-181 3 mg/kg	蓋鹽積範廠憲網淵壓積(鑰廠壓網鏇襯範壓築膚) = 蓋獵壓醖顧壓鬱簾醖構膚窪鹽夢遞繭蓋築淵遞 (遞選蓋鏇鹽壓艱顧窪範, 31 ~ 59) 更多