相关临床试验
269
56 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1964
进行中（未招募）
40
14.9%
已完成
105
39.0%
Enrolling By Invitation
1
0.4%
尚未招募
15
5.6%
招募中
85
31.6%
暂停
3
1.1%
终止
16
6.0%
撤回
4
1.5%
暂无批准数据
- Alligator Bioscience has signed a letter-of-intent with French non-profit clinical cancer research organization Unicancer to explore a global investigator-sponsored Phase 3 study of mitazalimab in first-line metastatic pancreatic cancer. - Mitazalimab is a tumor-directed immuno-oncology antibody drug targeting the CD40 receptor that previously demonstrated unprecedented survival data at 30-months follow-up in Phase 2 trials. - The collaboration represents an alternative development pathway as Alligator continues partnering activities, though no final development decisions have been made and activities remain exploratory. - Pancreatic cancer remains a challenging malignancy with limited therapeutic options, representing the fourth leading cause of cancer-related deaths globally with only a 10% five-year survival rate.
- Intensity Therapeutics' INVINCIBLE-4 Phase 2 study shows 71.4% pathological complete response rate with INT230-6 plus standard care versus 33% with standard care alone in triple-negative breast cancer patients. - The combination therapy demonstrated 44% fewer grade 3 or higher adverse events compared to standard immunochemotherapy alone, suggesting improved safety profile. - The company has submitted a protocol amendment to Swiss regulators to resume enrollment after addressing skin irritation issues with modified dosing parameters. - Results support INT230-6's potential for FDA accelerated approval pathway, as pathological complete response is an accepted surrogate endpoint for high-risk breast cancer.
- The ASTER 70 phase III trial involving 1,089 patients aged 70 and older with high-risk ER+HER2- breast cancer found no significant overall survival benefit from adding chemotherapy to hormone therapy. - After 7.8 years of follow-up, four-year survival rates were 90.5% with chemotherapy versus 89.3% with hormone therapy alone, while eight-year rates were 72.7% versus 68.3% respectively. - Patients receiving chemotherapy experienced significantly more grade 3 or higher adverse events (34% versus 9%) and reported worse quality of life including increased fatigue, pain, and digestive disorders. - The findings challenge current treatment standards and support more individualized approaches for elderly breast cancer patients based on age, frailty, and patient preferences rather than tumor biology alone.
• Natera has enrolled the first patients in the HEROES phase II clinical trial, investigating the potential to safely discontinue anti-HER2 therapy in metastatic breast cancer patients with no detectable circulating tumor DNA. • The trial will use Natera's Signatera test to identify patients who may safely stop maintenance therapy, potentially freeing them from lifelong treatment regimens that can be costly and cause adverse effects. • Approximately 170 patients across 35 French sites will participate in the study, which could fundamentally change treatment approaches for the 15-20% of breast cancer patients with HER2-positive tumors.
- Greenwich LifeSciences broadens its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence, by adding new clinical sites in the U.S. and Europe. - The trial expands into France through a partnership with Unicancer, activating 19 sites, and collaborates with GBG in Germany, adding approximately 38 sites to the study. - Harvard and Johns Hopkins join the trial in the U.S., with principal investigators Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee. - EMA approves the addition of 11 sites in Spain, Germany, and Poland, potentially activating 110-115 sites in Europe, with plans to expand to Ireland, Romania, and other countries.
- The HypoG-01 trial demonstrates that a 3-week hypofractionated radiotherapy regimen is equivalent to a 5-week normofractionated regimen for locoregional breast cancer. - The study included 1,265 patients and found no significant difference in lymphoedema onset, locoregional relapse-free survival, or overall survival between the two regimens. - The 3-week hypofractionated course is now a standard of care for women with node-invasive breast cancer, offering convenience and reduced burden. - This academic study highlights France's capability to conduct impactful clinical trials, providing direct benefits for patients and healthcare systems.
