相关临床试验
46
13 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
N/A
进行中（未招募）
13
28.3%
Available
2
4.3%
已完成
15
32.6%
招募中
6
13.0%
终止
7
15.2%
撤回
3
6.5%
暂无批准数据
- Agenus announced an oversubscribed private placement of up to $340 million, with $85 million upfront and up to $255 million upon full warrant exercise, to fund the registrational Phase 3 ROBBIN trial. - The ROBBIN trial will evaluate neoadjuvant botensilimab plus balstilimab (BOT+BAL) in high-risk Stage II/III microsatellite-stable (MSS) colon cancer, a population with no new curative-intent therapies approved in over 20 years. - Phase 2 data from NEST and UNICORN trials showed pathologic complete response rates of approximately 30% and major pathologic response rates of 35-40%, with all treated patients remaining disease free at median follow-up of 9 to 18 months. - Agenus is discontinuing financial support for the BATTMAN Phase 3 trial in late-line metastatic MSS colorectal cancer to focus resources on the neoadjuvant opportunity.
- The checkpoint inhibitor refractory cancer market is expected to grow significantly by 2036, driven by rising resistance to immune checkpoint inhibitors and demand for next-generation therapies. - Approximately 40–60% of patients with melanoma, NSCLC, renal cell carcinoma, urothelial carcinoma, and head and neck cancers experience primary resistance to PD-1/PD-L1 inhibitor therapy. - Promising investigational therapies include Sitravatinib + Nivolumab, TAVO + Pembrolizumab, Botensilimab + Balstilimab, and ICT01, which aim to overcome resistance and restore antitumor immunity. - The United States accounted for the largest checkpoint inhibitor refractory cancer treatment market size in the 7MM in 2025.
- France's National Agency for Medicines and Health Products Safety (ANSM) has approved compassionate access for Agenus' botensilimab plus balstilimab combination in patients with refractory microsatellite-stable metastatic colorectal cancer. - The treatment is fully reimbursed by France's Assurance Maladie for eligible patients meeting specific criteria, including MSS status and no active liver metastases. - Clinical data from Phase 1b trials demonstrate a 20% objective response rate and median overall survival of 20.9 months in heavily pretreated MSS colorectal cancer patients. - The global Phase 3 BATTMAN trial is set to launch in November 2025, enrolling 834 patients to evaluate the combination against best supportive care.
- A phase 1 trial of 148 patients demonstrated that the combination of botensilimab and balstilimab immunotherapy drugs successfully treated microsatellite stable metastatic colorectal cancer, the most common form that has historically not responded to immunotherapy. - The study found that 61% of patients experienced tumor shrinkage or stabilization after six months of treatment, marking the first time consistent and durable responses to immunotherapy have been reported in this difficult-to-treat patient population. - The treatment was well-tolerated with common side effects including diarrhea and fatigue, and showed particular effectiveness in patients without liver metastases. - Agenus Inc. is planning to seek FDA approval and has initiated a phase 3 clinical trial, potentially offering new hope for colorectal cancer patients who face limited treatment options.
