Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia

A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are:
* Does visugromab help participants put weight back on and have a better appetite?
* Does visugromab help participants move more and better?
* What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug).
Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.

开始日期2026-04-16

申办/合作机构

CatalYm GmbH

NCT07219459

/ Recruiting临床2期

A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)

This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.

开始日期2026-03-19

申办/合作机构

CatalYm GmbH

NCT07246863

/ Recruiting临床2期

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).
The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

开始日期2025-10-07

申办/合作机构

CatalYm GmbH

100 项与维苏格罗单抗相关的临床结果

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100 项与维苏格罗单抗相关的转化医学

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100 项与维苏格罗单抗相关的专利（医药）

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项与维苏格罗单抗相关的文献（医药）

2025-01-30·Nature

Neutralizing GDF-15 can overcome anti-PD-1 and anti-PD-L1 resistance in solid tumours

Article

作者: Trojan, Jörg ; Vilalta-Lacarra, Anna ; Fettes, Petra ; Richly, Heike ; Akdemir, Julia ; Chun, Felix Kyoung Hwan ; Gajewski, Thomas F ; Hackl, Hubert ; Racca, Fabricio ; Esteban-Villarrubia, Jorge ; Rössler, Bernhard ; Reis, Henning ; Torres-Jiménez, Javier ; Bargou, Ralf ; Lloyd, Peter ; Wild, Peter ; Trajanoski, Zlatko ; Alonso, Guzman ; Landa-Magdalena, Ana ; Auckenthaler, Alexandra ; Hermann, Frank ; Schuler, Martin ; Schuberth-Wagner, Christine ; Gjorgjioska, Ana ; Rodriguez Ruiz, Maria-Esperanza ; König, David ; Koster, Kira-Lee ; Foerster, Friedrich ; Melero, Ignacio ; Goebeler, Maria-Elisabeth ; Auer, Marlene ; Saavedra, Omar ; Koll, Florestan J ; Machacek, Matthias ; Dutta, Aradhana ; Gromke, Tanja ; Fridman, Wolf H ; Galle, Peter R ; de Miguel Luken, Maria ; Eggenschwiler, Corinne ; Soto-Castillo, Juan José ; Liebig, Mara ; Sanduzzi-Zamparelli, Marco ; Dummer, Reinhard ; Garralda, Elena ; Hess, Dagmar ; Läubli, Heinz ; Rüschoff, Josef ; da Silva, Antonio ; Tereshchenko, Anastasiia ; Eggermont, Alexander M M ; Rüdiger, Manfred ; Calvo, Emiliano ; L'Huillier, Phil ; Haake, Markus ; Fortuny, Marta ; Koch, Christine ; Klar, Kathrin ; Gogolla, Falk ; Moreno, Irene ; Sayehli, Cyrus ; Joerger, Markus ; Sabat, Paula ; Oberoi, Arjun ; Hernando-Calvo, Alberto ; Schmitt, Andreas M ; Reichhardt, Daniela ; Schöniger, Sandra ; Lichtenegger, Felix S ; Ramelyte, Egle ; Zink, Carina ; de Velasco, Guillermo ; Martín-Liberal, Juan ; Reig, Maria ; Wischhusen, Jörg ; Leo, Eugen

Cancer immunotherapies with antibodies blocking immune checkpoint molecules are clinically active across multiple cancer entities and have markedly improved cancer treatment¹. Yet, response rates are still limited, and tumour progression commonly occurs². Soluble and cell-bound factors in the tumour microenvironment negatively affect cancer immunity. Recently, growth differentiation factor 15 (GDF-15), a cytokine that is abundantly produced by many cancer types, was shown to interfere with antitumour immune response. In preclinical cancer models, GDF-15 blockade synergistically enhanced the efficacy of anti-PD-1-mediated checkpoint inhibition³. In a first-in-human phase 1-2a study (GDFATHER-1/2a trial, NCT04725474 ), patients with advanced cancers refractory to anti-PD-1 or anti-PD-L1 therapy (termed generally as anti-PD-1/PD-L1 refractoriness) were treated with the neutralizing anti-GDF-15 antibody visugromab (CTL-002) in combination with the anti-PD-1 antibody nivolumab. Here we show that durable and deep responses were achieved in some patients with non-squamous non-small cell lung cancer and urothelial cancer, two cancer entities identified as frequently immunosuppressed by GDF-15 in an in silico screening of approximately 10,000 tumour samples in The Cancer Genome Atlas database. Increased levels of tumour infiltration, proliferation, interferon-γ-related signalling and granzyme B expression by cytotoxic T cells were observed in response to treatment. Neutralizing GDF-15 holds promise in overcoming resistance to immune checkpoint inhibition in cancer.

2015-07-01·Arteriosclerosis, thrombosis, and vascular biology1区 · 医学

Choline Transporter-Like Protein-2

1区 · 医学

Article

作者: Ulrich J. Sachs ; Yudy Tjahjono ; Hans Deckmyn ; Heike Berghöfer ; Silke Werth ; Behnaz Bayat ; Sentot Santoso ; Simon F. De Meyer

Objective—:

In contrast to other antibodies involved in transfusion-related acute lung injury, anti–HNA-3a antibodies are incapable of inducing direct neutrophil activation and seem to interact with endothelial cells (ECs) primarily. In animal studies, anti–HNA-3a-mediated transfusion-related acute lung injury could be precipitated in the absence of neutrophils, but was stronger when neutrophils were present. In a different context the target protein of these antibodies, choline transporter-like protein-2 (CTL-2), was reported to interact with a protein of the inner ear carrying 2 von Willebrand factor (VWF) A-domains. These observations prompted us to investigate whether VWF might be involved in anti–HNA-3a-mediated neutrophil activation, and whether signaling via CD11b/CD18 is involved, as in various other experimental settings.

Approach and Results—:

Cell adhesion demonstrated specific binding of CTL-2 to VWF. Immunoprecipitation analysis of CTL-2/CD11b/CD18 coexpressing cells indicated that anti–HNA-3a colocalizes CTL-2 and CD11b/CD18 when VWF is present. Functional studies revealed that anti–HNA-3a-mediated neutrophil agglutination is an active, protein kinase C-dependent and partially Fc-dependent process. Agglutination and the production of reactive oxygen species seem to require the formation of a trimolecular complex between the target antigen (CTL-2), CD11b/CD18 and VWF. In line with these observations, anti–HNA-3a induced less severe transfusion-related acute lung injury and less neutrophil recruitment to the alveolar space in VWF knockout mice.

Conclusions—:

We introduce CTL-2 as a new binding partner for VWF. Interaction of neutrophils with VWF via CTL-2 allows anti–HNA-3a to induce signal transduction via CD11b/CD18, which leads to neutrophil activation and agglutination. In transfusion-related acute lung injury, this mechanism may further aggravate endothelial leakage.

项与维苏格罗单抗相关的新闻（医药）

2026-04-23

·Business Wire

CatalYm Advances Visugromab into Phase 2/3 Development for Cancer Cachexia with First Patient Dosed

MUNICH & SAN FRANCISCO--(BUSINESS WIRE)--CatalYm today announced that the first patient has been dosed in the Phase 2/3 VINCIT trial (Visugromab IN Cachexia International Trial, NCT07112196). The global study is evaluating the company’s lead anti-GDF-15 antibody visugromab in patients with cancer-associated cachexia. The randomized, double-blind, placebo-controlled Phase 2/3 trial will enroll about 518 patients with cachexia associated with a range of advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors. Cachexia is a severe metabolic condition marked by involuntary weight loss, muscle wasting, and impaired treatment tolerance. In some types of cancer, it can affect up to 70% of patients and is responsible for 20-40% of cancer-related deaths1. Elevated GDF-15 levels are known to play a central role in the development of cachexia. Despite a high unmet medical need, there are currently no approved pharmacological treatments available. “Cachexia remains one of the most debilitating and under-addressed complications in oncology,” said Sujata Rao, MD, Chief Medical Officer at CatalYm. “Following the promising weight gain data observed in our earlier trial and growing evidence of GDF-15’s role in metabolic wasting, this trial is a critical step in establishing visugromab as a novel therapeutic option for patients with advanced cancers.” “The data guiding this trial show that GDF-15 is more than a bystander in cancer progression. It plays a central role in both immune resistance and metabolic decline,” said Scott Clarke, Chief Executive Officer at CatalYm. “By targeting GDF-15, visugromab has the potential to open a new therapeutic path for patients whose treatment outcomes are severely impacted by cachexia.” The VINCIT trial is an adaptive Phase 2/3 study to evaluate the efficacy and safety of visugromab in reversing cachexia. In Part 1, participants are randomized to receive one of three visugromab dose levels or placebo every four weeks for 12 weeks. Based on interim analyses, a recommended dose will be selected for Part 2, which will randomize patients 2:1 to visugromab or placebo for up to 52 weeks. The trial will include clinical sites across the globe. Primary endpoints include changes in body weight and appetite over 12 weeks. Secondary endpoints assess muscle mass and function, physical activity, tumor response, overall survival, patient-reported quality of life, and safety. The study also includes exploratory pharmacodynamic and biomarker assessments. Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and cachexia. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab in combination with PD-1 inhibitor nivolumab demonstrated deep and durable anti-tumor activity as well as a favorable safety profile in patients with relapsed or refractory NSCLC, hepatocellular carcinoma (HCC) and urothelial cancer (UC). The trial also provided early clinical evidence for visugromab’s potential to alleviate cancer cachexia, including meaningful weight gain in the subset of patients with moderate or severe weight loss at trial entry. These findings support visugromab’s dual potential to maintain or restore immune function and counteract cancer cachexia. About cancer cachexia and GDF-15 Cancer cachexia is a complex and debilitating syndrome that affects up to 70% of patients with advanced cancer1. The condition is closely linked to elevated GDF-15 levels, which drive severe and progressive weight loss, muscle wasting, reduced appetite, and metabolic disturbances through activation of the GFRAL receptor in the brainstem. Unlike starvation, cachexia cannot be fully reversed with nutritional support alone, as it is driven by a combination of systemic inflammation, tumor-derived factors, and metabolic dysregulation. This condition significantly diminishes the quality of life for cancer patients and severely impacts their ability to tolerate and respond to treatment, often leading to poorer outcomes and increased mortality. About Visugromab Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated deep and durable anti-tumor efficacy with long-lasting objective responses in relapsed and checkpoint refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC (NCT07098988), second-line metastatic non-squamous NSCLC (NCT07246863), second-line hepatocellular carcinoma (NCT07219459) and cachexia (NCT07112196). Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion. 1 Fearon K. et al. Lancet Oncol. 2011;12(8):489–495.

临床结果临床2期免疫疗法临床1期

2026-04-07

·BioSpace

CatalYm Doses First Patient in Phase 2b Trial Evaluating Visugromab in Combination with Chemoimmunotherapy as Second-Line Treatment in Unresectable/Metastatic Hepatocellular Carcinoma

Study targets patients with unresectable or metastatic hepatocellular carcinoma who have progressed following first-line anti-PD-(L)1-based therapy Initiation of the third Phase 2b study of visugromab, expanding development into hepatocellular carcinoma following first and second-line NSCLC programs MUNICH & SAN FRANCISCO--(BUSINESS WIRE)-- CatalYm today announced that the first patient has been dosed in the GDFATHER-HCC-01 trial ( NCT07219459 ). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab in combination with chemoimmunotherapy as a second-line (2L) treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The Phase 2b trial targets patients who have progressed following 1L treatment with an anti-PD-(L)1-based therapy. The trial will assess a treatment strategy combining visugromab with the PD-1 inhibitor nivolumab and the multi-target tyrosine kinase inhibitor (TKI) lenvatinib. The study consists of an open-label safety run-in to confirm the recommended dose for expansion, followed by a randomized, double-blind phase evaluating visugromab plus nivolumab plus lenvatinib versus double placebo plus lenvatinib. Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), an immunosuppressive cytokine exploited by tumor cells to promote immune evasion and resistance to anti-PD-(L)1 therapies. By neutralizing GDF-15, visugromab aims to restore anti-tumor immune responses to improve outcomes in a setting where 5-year overall survival remains as low as 18%. 1 In the exploratory Phase 1/2a GDFATHER trial ( NCT04725474 ), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory HCC patients, demonstrating deep and durable responses, with a median duration of response of 21.4 months and a favorable safety profile. “HCC is the third leading cause of cancer-related deaths globally and continues to present immense clinical challenges, especially in patients who progress on immunotherapy,” said Sujata Rao, MD, Chief Medical Officer at CatalYm . “This new trial is designed to combine the immune-restoring properties of visugromab with a checkpoint inhibitor and the standard of care tyrosine kinase inhibitor. With this approach we aim to improve clinical outcomes for HCC patients with limited treatment options.” “Expanding into HCC represents a pivotal step in our strategy to bring visugromab to additional high-need tumor types,” said Scott Clarke, Chief Executive Officer at CatalYm . “Visugromab’s dual potential to restore immune sensitivity and address cancer cachexia, which affects nearly one in four patients with HCC at diagnosis, underpins our approach in this study. By combining our antibody with proven standards of care, we aim to shift the treatment paradigm and ultimately improve survival and quality of life for patients who have few options today.” The GDFATHER-HCC-01 trial is a global, randomized, blinded Phase 2b study enrolling approximately 104 participants across 40 sites in North America, Europe and Asia-Pacific. It consists of two parts: Part 1: An open-label safety run-in assessing the combination of visugromab with nivolumab and lenvatinib to determine the Recommended Dose for Expansion (RDE). Part 2: A randomized and double-blind evaluation of the triple combination versus double placebo plus lenvatinib. The primary endpoint is progression-free survival (PFS) assessed by local investigators. Key secondary endpoints include overall survival (OS), independently assessed PFS, and objective response rate (ORR). The study will also explore visugromab’s potential to mitigate cancer cachexia using the Functional Assessment of the Anorexia and Cachexia Therapy questionnaire (FAACT-ACS), as muscle wasting and weight loss are common in HCC and known to negatively affect treatment tolerance and clinical outcomes. About Hepatocellular Carcinoma Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. The five-year survival rate for HCC is only 18%, second lowest among common cancers 1 . While checkpoint inhibitors have become a first-line standard of care, most patients with advanced-stage HCC ultimately experience disease progression or relapse. Treatment options in the second-line setting remain limited, underscoring the urgent need for more effective and well-tolerated therapies. About Visugromab Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated deep and durable anti-tumor efficacy with long-lasting objective responses in relapsed and checkpoint refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC ( NCT07098988 ), second-line metastatic non-squamous NSCLC ( NCT07246863 ), and second-line hepatocellular carcinoma ( NCT07219459 ). Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion. 1 National Institute of Health, Hepatocellular Carcinoma , retrieved on January 14, 2026 Contacts CatalYm GmbH Clinton Musil, CFO and CBO info@catalym.com Media Inquiries Trophic Communications Dr. Stephanie May or Anja Heuer Phone: +49 171 185 56 82 or +49 151 106 199 05 catalym@trophic.eu

临床2期免疫疗法临床结果ASCO会议

2026-03-24

·中金财富证券

医药生物行业：创新药 GDF-15 恶病质治疗进入关键临床阶段

据今日投资在线分析师统计数据显示，机构对制药行业的关注度近一周提升，目前升至第4，较一周前上升2位。 GDF-15阻断剂有望治疗肿瘤恶病质、提升PD-（L）1疗效。肿瘤恶病质全球患者超100万人并且尚无针对性药物获批；约50-85%患者会对PD-（L）1产生耐药。GDF-15阻断剂已在II期临床概念性验证其在恶病质治疗中的疗效，并且目前已进入注册临床阶段，中信证券认为GDF-15阻断剂有望获批治疗肿瘤恶病质；GDF-15阻断剂联合PD-（L）1疗法在早期临床阶段展现出积极数据，目前已经开展多个II期临床试验，但仍需后续临床概念性验证。中信证券认为GDF-15阻断剂有望在未来获批治疗肿瘤恶病质，诞生multi-billion美元的单品。 GDF-15阻断剂具备治疗肿瘤恶病质、提升PD-（L）1疗效的潜力。 GDF-15是TGF-β超家族的一个特殊成员，在1997年首次被发现（Bootcov 1997）。2017年GDF-15受体GFRAL被发现完善了GDF-15生物学机制，表明其是治疗肿瘤恶病质的潜在靶点（Emmerson 2017）。2023年GDF-15抑制T细胞LFA-1/ICAM-1轴的发现表明GDF-15有望克服PD-（L）1耐药（Markus 2023）。随后辉瑞、CatalYm等公司开展的多项临床试验表明GDF-15有望治疗肿瘤恶病质、提升PD-（L）1疗效。 GDF-15阻断剂有望获批治疗肿瘤恶病质，诞生multi-billion美元的单品。肿瘤恶病质提升了约58%的死亡风险（Takaoka 2024），癌症患者中肿瘤恶病质的患病率约30%（Takaoka 2024），中美目前尚无针对性药物获批，市场呈现空白状态。辉瑞公司目前处于IIb/III期注册阶段的GDF-15在研药物Ponsegromab的II期数据优异，400mg剂量（n=50）12周相对安慰剂（n=45）增重超5%（2025 Pflash）。中信证券认为GDF-15阻断剂有望获批治疗肿瘤恶病质，涉及全球患者人数超100万人，有望诞生multi-billion美元的单品。 GDF-15阻断剂有望提升PD-（L）1疗效，但仍需概念性验证。肿瘤免疫治疗中的一大难题是标准疗法PD-（L）1耐药，约50-85%患者初始治疗时耐药（Melero 2025）。早期临床中，Catalym公司的GDF-15在研药物Visugromab联用纳武利尤单抗治疗末线PD-（L）1耐药病人可以将约0-5%的ORR（总体应答率）提升至14%-18%（2025 ESMO），并且在未接受过抗PD-（L）1治疗的MIBC患者中，在术前新辅助治疗加入Visugromab可使纳武利尤单抗的疗效提高3倍（2025 ESMO）。Catalym目前已开展的多个Visugromab联用PD-（L）1在1L、2L、新辅助疗法中的II期临床试验。中信证券认为该概念仍处于早期阶段，仍需在后续的临床试验中被验证。风险因素：新药研发进度不及预期或失败的风险；新药审批进度不及预期或不通过的风险；新药上市后疗效安全性不及预期风险；产品商业化不及预期以及销售不利的风险；市场竞争格局变化的风险；医药政策超预期变化的风险；统计数据偏差风险。投资策略：GDF-15阻断剂目前具备潜在的治疗肿瘤恶病质以及提升PD-（L）1疗效的能力，其中针对肿瘤恶病质的治疗在II期临床中得到了验证，但是其提升PD-（L）1疗效的初步效果仅在早期小样本临床试验中得到积极信号，仍需后续临床验证。目前GDF-15阻断剂行业处于临床开发阶段，尚无任何药物获批，多数临床管线处于早期阶段，进度最快的为辉瑞公司和CatalYm公司。辉瑞公司的GDF-15靶点在研药物Ponsegromab在肿瘤恶病质适应症中有效性和安全性数据较好，成药可能性大并且目前已经进入注册临床阶段，进度领先。Catalym公司的GDF-15靶点在研药物Visugromab在PD-（L）1耐药患者治疗中的早期临床试验数据优异，目前已开展4个临床II期试验，在PD-（L）1联用中进度领先，但仍需更多数据验证。鉴于Ponsegromab在II期临床试验中的优异结果以及Ponsegromab的II/III期临床试验设计，中信证券认为其有望获批治疗肿瘤恶病质，成为GDF-15阻断剂上市后第一个适应症。中信证券测算肿瘤恶病质全球患病人数超100万人，市场空间庞大，中信证券认为该市场有望诞生multi-billion美元的单品。后续如果Ponsegromab成功上市以及Visugromab读出积极数据，将催化GDF-15阻断剂市场快速增长。建议关注国内具备进度较快且成药性较高的GDF-15管线的公司。中信证券建议关注国内具备GDF-15资产且处于领先定位以及临床试验数据优秀的公司。

100 项与维苏格罗单抗相关的药物交易

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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
恶病质	临床3期	美国	CatalYm GmbH	2026-04-16
恶病质	临床3期	保加利亚	CatalYm GmbH	2026-04-16
恶病质	临床3期	法国	CatalYm GmbH	2026-04-16
恶病质	临床3期	挪威	CatalYm GmbH	2026-04-16
恶病质	临床3期	西班牙	CatalYm GmbH	2026-04-16
恶病质	临床3期	瑞士	CatalYm GmbH	2026-04-16
肝细胞癌	临床2期	德国	CatalYm GmbH	2026-03-19
肝细胞癌	临床2期	意大利	CatalYm GmbH	2026-03-19
转移性非小细胞肺癌	临床2期	美国	CatalYm GmbH	2025-08-01
转移性非小细胞肺癌	临床2期	德国	CatalYm GmbH	2025-08-01

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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


NCT04725474 (GDFATHER-01, SITC2025)	临床1/2期	肝细胞癌 \| 局部晚期非鳞状非小细胞肺癌	77	Visugromab (10mg/kg) + Nivolumab (240mg)	遞齋築鏇鹽餘膚淵構簾(壓範衊糧鏇窪觸齋簾窪) = reported in 10/77 (13.0%) pts 鏇夢鑰襯餘襯廠構淵獵 (餘壓範觸衊選齋選選艱 )	积极	2025-11-05
NCT04725474 (GDFATHER-01, ESMO2025)	临床1/2期	肝细胞癌 \| 非小细胞肺癌 \| 尿路上皮癌	77	Visugromab (V) + Nivolumab (N) (non-squamous NSCLC + urothelial cancer + hepatocellular cancer + anti-PD1/-L1 relapsed/refractory)	網廠鹹膚鑰壓範淵遞壓(壓願範壓遞壓觸襯顧鏇) = 鹽餘觸憲壓顧鬱齋夢餘範窪鬱鑰築遞餘廠艱繭 (襯願鏇繭壓鹽遞衊積鑰 ) 更多	积极	2025-10-17
NCT06059547 (GDFather-NEO, ESMO2025)	临床2期	肌层浸润性膀胱癌新辅助	31	Nivolumab+Visugromab	膚選鏇顧觸壓構遞繭衊(膚觸壓獵膚齋艱蓋積窪) = 衊艱襯衊衊鏇淵壓遞膚蓋鹹獵膚鬱醖鬱鹽鬱構 (範積鹽壓遞遞壓淵獵憲 ) 更多	积极	2025-10-17
NCT06059547 (GDFather-NEO, ESMO2025)	临床2期	肌层浸润性膀胱癌新辅助	31	Nivolumab+Placebo	膚選鏇顧觸壓構遞繭衊(膚觸壓獵膚齋艱蓋積窪) = 範鏇壓製選憲艱夢膚選蓋鹹獵膚鬱醖鬱鹽鬱構 (範積鹽壓遞遞壓淵獵憲 ) 更多	积极	2025-10-17
NCT04725474 (GDFATHER, BusinessWire) 人工标引	临床1/2期	肝细胞癌 \| 实体瘤 \| 非鳞状非小细胞肺癌 ... 更多	-	visugromab (non-squamous NSCLC)	鬱築積憲網鹹繭選衊鏇(鹹製壓醖廠鹹艱鏇蓋繭) = 簾觸餘鹽鹹築繭鑰糧鹽蓋窪簾網衊膚願餘鏇觸 (夢衊築衊憲獵廠網網鹽 ) 更多	积极	2024-12-11
NCT04725474 (GDFATHER, BusinessWire) 人工标引	临床1/2期	肝细胞癌 \| 实体瘤 \| 非鳞状非小细胞肺癌 ... 更多	-	visugromab (UC)	鬱築積憲網鹹繭選衊鏇(鹹製壓醖廠鹹艱鏇蓋繭) = 夢構壓鑰鬱範鬱淵齋築蓋窪簾網衊膚願餘鏇觸 (夢衊築衊憲獵廠網網鹽 ) 更多	积极	2024-12-11
NCT04725474 (GDFATHER, Biospace) 人工标引	临床1/2期	肝细胞癌 \| 非小细胞肺癌 \| 尿路上皮癌	-	Visugromab + Nivolumab	壓餘築窪襯壓遞壓遞觸(齋鏇憲廠糧糧獵衊壓鏇) = 築範餘範壓築壓餘夢襯構鏇鑰顧鬱廠鑰憲構衊 (繭獵繭廠鑰齋淵繭遞壓 )	积极	2024-06-02
NCT04725474 (GDFATHER, Biospace) 人工标引	临床1/2期	肝细胞癌 \| 非小细胞肺癌 \| 尿路上皮癌	-	Visugromab + Nivolumab (NSCLC)	衊鬱製膚網鑰艱憲鹹選(糧觸顧簾範艱構選觸艱) = 淵膚範鹹觸遞齋築窪膚鬱觸餘鬱觸獵壓醖鏇餘 (築顧築窪艱範構繭鏇願 )	积极	2024-06-02
NCT04725474 (GDFather, ASCO2024) 人工标引	临床2期	肝细胞癌 \| 鳞状非小细胞肺癌 \| 尿路上皮癌	87	Visugromab 10 mg/kg + Nivolumab 240 mg Q2W	獵願鬱鹹衊膚製齋窪襯(築鑰夢蓋艱鏇襯蓋襯築) = 繭憲獵鬱製餘襯簾顧鹽構繭憲壓觸鏇遞範願選 (鹹鬱顧範選範構齋襯網 ) 更多	积极	2024-05-24
NCT04725474 (GDFather, ASCO2024) 人工标引	临床2期	肝细胞癌 \| 鳞状非小细胞肺癌 \| 尿路上皮癌	87	Visugromab 10 mg/kg + Nivolumab 240 mg Q2W (NSCLC)	-	积极	2024-05-24
NCT04725474 (GDFATHER-2, Biospace) 人工标引	临床2期	晚期非小细胞肺癌 \| 尿路上皮癌 PD-L1 Positive	27	Visugromab+nivolumab (NSCLC)	繭鹽壓構願繭齋遞築積(積壓觸積構憲觸夢壓淵) = 願繭齋簾築鹽艱築鹽積網構遞繭壓餘糧淵構壓 (醖範鹹壓觸積鬱製蓋憲 )	积极	2023-12-06
NCT04725474 (ESMO_IO2023)	临床2期	实体瘤 \| 非小细胞肺癌 \| 膀胱癌 PD-L1+	114	Visugromab 10 mg/kg + Nivolumab 240 mg	窪獵鹹淵範製醖獵憲蓋(夢繭壓繭蓋積廠願觸鏇) = 淵製選鹽淵窪鏇醖醖窪獵襯淵範顧願範膚壓築 (壓艱膚繭觸醖鑰蓋範壓 )	积极	2023-12-06
NCT04725474 (GDFATHER, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	实体瘤	79	Nivolumab 240 mg+visugromab 10 mg/kg	鬱繭淵夢衊鬱製簾淵夢(醖願夢鑰齋淵築淵衊餘) = 膚簾製鏇築鹹鏇艱糧齋構簾鹽製選網構鏇壓夢 (窪餘糧鑰鑰構艱顧蓋簾 ) 更多	积极	2023-05-31
NCT04725474 (GDFATHER-1, ESMO2022) 人工标引	临床1期	复发性实体肿瘤	25	CTL-002 0.3-20 mg/kg+Nivolumab	積觸遞願鹹壓願淵獵壓(廠選廠糧遞鹹衊製蓋窪) = 鬱遞壓壓壓齋願醖壓淵憲觸獵鹹壓淵繭構繭艱 (廠積窪淵醖醖餘鏇鏇襯 ) 更多	积极	2022-09-10