A Study Evaluating the Safety, Tolerability, Pharmacokinetic and Efficacy of HLX301(TIGIT×PDL1 Bispecific)...
Advanced TumorsLymphoma1 moreA Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in patients with locally advanced/metastatic solid tumors or lymphoma.Up to 150 patients will be included in this study. Up to 30 DLT evaluable patients will be enrolled in phase 1a (dose escalation), 40 per-protocol treated patients in phase 1b (dose expansion), and 80 per-protocol treated patients in phase 2. Phase 1a to evaluate safety, dose limiting toxicity (DLT), and the maximum tolerated dose (MTD) of HLX301 in patients with advanced or metastatic tumors who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.Phase 1b to identify the recommended phase 2 dose (RP2D) of HLX301 in patients with advanced or metastatic NSCLC who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. Phase 2 to evaluate the anti-tumor activity of HLX301 in patients with histologically or cytologically-confirmed non-small cell lung cancer (NSCLC), gastric/esophagogastric junction adenocarcinoma (GC/EGJ), head and neck squamous cell carcinoma (HNSCC), or urothelial carcinoma (UC) tumors that express PD-L1, after one or two prior systemic treatments and without standard therapy。
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Advanced CancerMetastatic CancerMulticenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab
Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis...
Gastric CancerPeritoneal MetastasesGastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously. Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.
The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients...
Brain MetastasesNsclcPatients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life. Therapy options for multiple brain metastases may vary and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.
SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study
Vertebral MetastasisSPINERY is a Radiofrequency (RF) device designed for palliative treatment of patients with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum. In particular, SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies, sacrum, iliac crest and periacetabulum, in patients with indication for Standard Therapy and in patients who have failed, not candidates or refuse Standard Therapy. Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term (3 months) pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors, without causing device-related adverse events including, in particular, nerve injury. Primary objective hypothesis will be obtained with Brief Pain Inventory (BPI) scale performance questionnaire in terms of palliative treatment. Change of Worst Pain Score expressed as average reduction of 2 BPI (Brief Pain Inventory) scores will be calculated as: μc = worst-pain 3-month - worst-pain baseline A negative average value for change in pain represents a lowering of the subject's pain score (an improvement, or reduction in pain) and a positive value represents an increase in the subject's pain score (a worsening or increase in pain). Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours.
Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases...
Advanced Colorectal CarcinomaLiver Metastasis Colon CancerFruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Combined with hepatic arterial infusion chemotherapy (HAIC), this study is conducted to assess the efficacy and safety of this regimen in patients with unresectable colorectal cancer liver metastases as the third-line therapy.
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
Advanced CancerMetastatic Cancer1 moreThis study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia
CachexiaThis open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in metastatic cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases...
Colorectal Liver MetastasesTislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases. NCCN guidelines and several expert consensus recommend that regional hepatic arterial infusion chemotherapy can be considered as a "rescue treatment" for patients with colorectal cancer liver metastases who fail to receive first-line or second-line systemic chemotherapy, which can significantly prolong the overall survival of patients.
Study Assessing QBS72S For Treating Brain Metastases of Breast Cancer
Brain MetastasesBreast CancerThis study is to evaluate the efficacy and safety of QBS72S in participants with advanced, relapsed, metastatic breast cancer with CNS involvement.