Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced...
Brain MetastasesTo learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.
Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Regorafenib as Adjuvant Therapy...
Colorectal Liver MetastasisPts with histologically confirmed CRLM and whose CRS >2 were enrolled into this single-arm, phase II study. The critical enrollment criteria were that Subjects had completely resected Primary lesion and liver metastases and had no evidence of extrahepatic disease. After hepatectomy, HAIC (FOLFOX: oxaliplatin 85mg/m2, 5- fluorouracil 2500mg/m2, calcium folinate 400mg/m2) was given every 4-6 weeks for 2-4 cycles depending on pts' health status, in combination with Sintilimab (200mg, iv, d1) and regorafenib (80mg, po, d1-21) every 3 weeks for up to 6 months. The primary endpoint was 1-year recurrence-free survival (RFS) and secondary endpoints included RFS, overall survival (OS), safety, and health-related quality of life.
A Phase 1 Study With ABBV-CLS-484 in Subjects With Locally Advanced or Metastatic Tumors
Advanced Solid Tumor CancerThe study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis...
NSCLCBrain Metastases1 moreAlmonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study aims to explore the efficacy and safety of different doses of almonertinib in the first-line and second-line treatment of brain metastases/meningeal metastases in NSCLC patients.
Metastatic Solid Cancer Clinical Trial
Metastatic CancerThis study seeks to estimate the potential efficacy of the study treatment, as well as the occurrence of adverse events.
A Phase 2 Trial for Patients With Metastatic Solid Cancer
Metastatic CancerThis study seeks to estimate the potential efficacy of the study treatment, as well as the occurrence of adverse events.
DNX-2440 for Resectable Colorectal Liver Metastasis
Liver MetastasesLiver Metastasis Colon Cancer9 moreThe purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Spine MetastasesMetastasis SpineThis study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
Breast Cancer FemaleEarly-stage Breast Cancer3 moreRATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population. PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.
FS120 First in Human Study in Patients With Advanced Malignancies
Advanced CancerMetastatic CancerThis is a Phase 1, multicenter, open-label, multiple-dose, multi part, first in human study in adult subjects with specific advanced malignancies. The study is designed to systematically assess safety, and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, clinical activity and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS120 as a monotherapy and in combination with pembrolizumab.