相关临床试验
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0 进行中
药物批准
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监管机构
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成立时间
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招募中
2
66.7%
暂无批准数据
- A Fudan University Shanghai Cancer Center study found the Nectin-4-targeted tracer [68Ga]Ga-FZ-NR-1 detected more lesions than FDG PET/CT in recurrent or metastatic triple-negative breast cancer. - The tracer achieved 98.13 percent sensitivity and 68.63 percent specificity versus 93.46 percent and 27.45 percent for FDG in a head-to-head comparison of 40 patients. - Baseline Nectin-4 scan parameters predicted outcomes, with high mean MTV40 linked to shorter progression-free survival (P=0.009) and a high heterogeneity index to shorter overall survival (P=0.008). - Authors describe the findings as hypothesis-generating, noting the single-institution design and the need for validation in larger multicenter cohorts.
- The HER2-LADDER model, integrating H&E and HER2 IHC digital pathology with clinical data, achieved an AUC of 0.944 in predicting pathological complete response to neoadjuvant TCbHP/PCbHP in HER2-positive breast cancer. - Each 0.1-unit increase in the HER2-LADDER score increased the odds of non-pCR nearly sevenfold (OR 6.628, 95% CI: 4.445–9.883), outperforming conventional predictors like HER2 IHC 3+ status and HR negativity. - The model stratified patients into Low, Medium, and High groups, suggesting potential for treatment de-escalation (THP, TCbH/PCbH) in Low-score patients and alternative regimens (ADCs, TKIs) in High-score patients. - Spatial transcriptomics revealed that HER2-LADDER-High tumors exhibit mosaic-like HER2 expression heterogeneity and reduced immune-hot phenotypes, providing biological interpretability for the model's predictions.
- Everest Medicines presented first-in-human clinical trial data for EVM16, a personalized mRNA cancer vaccine, at AACR 2026, demonstrating favorable safety profile with no dose-limiting toxicities observed across nine patients. - EVM16 elicited strong neoantigen-specific T cell responses in 8 of 9 patients with a dose-dependent trend, with one gastroesophageal junction cancer patient achieving confirmed partial response after failing three prior therapies. - The vaccine uses Everest's proprietary AI-based algorithm EVER-NEO-1 to predict patient-specific tumor neoantigens and employs lipid nanoparticle delivery to activate tumor-killing T cells. - The study evaluated EVM16 as monotherapy and in combination with PD-1 inhibitor tislelizumab across three dose levels in patients with advanced solid tumors who failed standard care.
- Ensem Therapeutics has dosed the first patient with ETX-636 in China at Fudan University Shanghai Cancer Center as part of its global Phase 1/2 clinical trial. - ETX-636 is a potential first-in-class allosteric pan-mutant-selective PI3Kα dual inhibitor and degrader targeting tumors with PI3Kα mutations, including breast cancer. - The drug employs a novel mechanism to selectively inhibit mutant PI3Kα while sparing wild-type PI3Kα, potentially offering superior tolerability compared to first-generation inhibitors. - Preliminary clinical data supporting proof of concept is expected to be disclosed in the second half of 2026.
- A phase 3 trial showed that camrelizumab plus famitinib significantly extended progression-free survival to 11.1 months compared to 7.5 months with platinum-based chemotherapy in recurrent or metastatic cervical cancer patients. - The chemotherapy-free combination also improved overall survival to 34.4 months versus 23.4 months with standard treatment, meeting both dual primary endpoints at interim analysis. - The treatment demonstrated a manageable safety profile with higher rates of treatment-related adverse events but provided durable responses with median duration of 17.9 months compared to 8.3 months for chemotherapy. - Results suggest this immunotherapy-targeted therapy combination could serve as a novel first-line treatment option for patients with recurrent or metastatic cervical cancer.
- CARsgen presented preliminary results from the world's first proof-of-concept study exploring CAR T-cell therapy for adjuvant treatment of solid tumors at ESMO Congress 2025. - The Phase Ib trial of satri-cel in high-risk pancreatic cancer patients achieved an 83.3% nine-month disease-free survival rate with significant CA19-9 biomarker reductions. - Only one of six patients experienced disease recurrence during a median follow-up of 6.05 months, with manageable safety profile including Grade 1-2 cytokine release syndrome. - The study enrolled patients with Claudin18.2-positive pancreatic ductal adenocarcinoma who had undergone curative resection but showed abnormal CA19-9 levels after standard chemotherapy.
- Everest Medicines achieved 48% year-over-year revenue growth to RMB 446 million in H1 2025, driven by strong performance of NEFECON® and XERAVA®. - The company's proprietary AI-enabled mRNA platform advanced significantly with EVM16 personalized cancer vaccine entering first-in-human trials and EVM14 receiving FDA IND clearance. - NEFECON® became the first etiological treatment for IgA nephropathy to receive full approval in China, with production expansion approved to meet growing demand. - EVER001, a next-generation BTK inhibitor, demonstrated encouraging Phase 1b/2a results in primary membranous nephropathy with sustained efficacy through 52 weeks.
- Researchers at Fudan University developed the Plasma Immuno Prediction Score (PIPscore) using six immune-related plasma proteins to predict immunotherapy response in triple-negative breast cancer with 85.8% accuracy. - The study identified key biomarkers ARG1, NOS3, and CD28 from analysis of 92 proteins in 195 TNBC patients, offering a non-invasive alternative to tumor biopsies for treatment prediction. - The PIPscore demonstrated 96% precision in predicting 12-month progression-free survival, potentially enabling personalized treatment strategies and early identification of non-responders. - This plasma proteomics approach addresses limitations of current biomarkers like PD-L1 expression by providing dynamic assessment of systemic immunity rather than tumor-localized signatures alone.
- Researchers developed and tested three Nectin-4-targeted PET radiotracers, with 68Ga-FZ-NR-1 showing the highest targeting efficacy in preclinical studies. - First-in-human study of 68Ga-FZ-NR-1 PET/CT in nine TNBC patients successfully identified tumors, with positive lesions corresponding to areas of high Nectin-4 expression confirmed by biopsy. - The radiotracer demonstrated strong hydrophilicity (log D7.4 = −3.55 ± 0.10) and high specificity for Nectin-4 (Kd = 2.81 nM) with significantly higher accumulation in Nectin-4-positive tumor cells. - This advancement represents a critical breakthrough for TNBC diagnosis, potentially revolutionizing treatment outcomes through more precise disease assessment and personalized therapeutic strategies.
- Everest Medicines has dosed the first patient with EVM16, its proprietary personalized mRNA cancer vaccine, in a first-in-human trial at Peking University Cancer Hospital in China. - The trial will evaluate EVM16's safety, immunogenicity, and efficacy both as monotherapy and in combination with PD-1 antibody in patients with advanced or recurrent solid tumors. - Preclinical studies demonstrated synergistic anti-tumor effects when EVM16 was combined with PD-1 antibodies, suggesting potential clinical benefits for cancer patients with limited treatment options.
