A Study of BDTX-4933 in Patients With BRAF and Select RAS/MAPK Mutation-Positive Cancers
Non-small Cell Lung CancerNon-small Cell Carcinoma31 moreBDTX-4933-101 is a first-in-human, open-label, Phase 1 dose escalation and multiple expansion cohort study designed to evaluate the safety and antitumor activity of BDTX-4933. The study population comprises adults with recurrent advanced/metastatic cancers harboring BRAF (Class I, II, and III), KRAS (other than G12C such as G12D, G12V), or NRAS mutations including non-small cell lung cancer (NSCLC), melanoma, histiocytic neoplasms, thyroid cancer, colorectal cancer, and other solid tumor cancers with or without brain metastases. All patients will self-administer BDTX-4933 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases...
CancerMetastasis4 moreTo determine the safety and efficacy of using the drug azeliragon combined with stereotactic radiosurgery. Specifically, to determine if this combination will lead to improved response in the brain (tumor shrinking in size) and overall tumor control (how long tumor remains controlled).
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small...
Non Small Cell Lung CancerStage IV Non-small Cell Lung Cancer1 moreThe objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.
Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program
Brain CancerCognitive ImpairmentThe aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.
Sonography-guided Resection of Brain Mass Lesions
TumorBrain3 moreObjective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.
(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
Lung Neoplasm MalignantCarcinoma21 moreThis is a Phase 1/2, open-label first-in-human study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.
Study of TY-9591 in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR...
NSCLCEGFR Activating Mutation2 moreTo evaluate the efficacy and safety of TY-9591 tablets in the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with brain or leptomeningeal metastases.
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation...
Brain TumorPrimaryAn open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation
Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable...
Brain MetastasesAdultThe research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.
A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With...
Brain TumorThis is a single center, multi-arm, biomarker-driven phase 1 study to assess the RP2D, PK/PD, safety, and activity of tepotinib in participants with MET alterations and brain tumors. Eligible patients include those with brain metastases or glioblastoma, including patients who are surgical candidates. In patients with EGFR+ NSCLC with EGFR-TKI resistance and MET amplification, tepotinib will be given in combination with osimertinib. This phase 1 study will be conducted in 2 parts, Phase 1a (dose exploration) and Phase 1b (dose expansion). Phase 1a will include a surgical resection window of opportunity component. Phase 1b (dose expansion) can open once the relevant RP2D has been estimated in Phase 1a (dose exploration). Phase 1a (Dose Exploration): Patients will be assigned to dose levels within a Group as outlined in the Statistical Analysis Plan. Group A will be comprised of patients who are surgical resection candidates with newly-diagnosed or recurrent brain metastases and MET alteration. Group B will be comprised of patients who are surgical resection candidates with recurrent glioblastoma and MET alteration. Group C will be comprised of patients with newly-diagnosed or recurrent brain metastases and epidermal growth factor receptor mutated (EGFR+) non-small cell lung cancer (NSCLC). Phase 1b (Dose Expansion): Upon completion of the Phase 1a (dose exploration) component and estimation of a RP2D, dose expansion may proceed within Group A (consisting of patients with brain metastasis and MET alteration) and Group C (EGFR+ NSCLC brain metastasis, TKI resistance, and MET amplification). Dose expansion in these 2 groups may be done concurrently, but enrollment in each group does not require completion of the entire Phase 1a component of the study. There will not be a Group B (glioblastoma) in Phase 1b. Patients in Phase 1b will not undergo surgical resection.