Clinical trials

The study is a Phase III, Randomized, Multi-center, Open-label study in HER2-low, HR+ metastatic breast cancer subjects whose disease has progressed on at least 2 lines of prior ET or within 6 months of first line ET + Cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. The primary purpose of the study is to determine the efficacy and safety of DB-1303/BNT323 compared with investigator's choice single agent chemotherapy in the target population. Approximately 532 subjects with HER2 IHC 2+/ISH- and IHC 1+ (HER2-low] expression will be randomized 1:1 across approximately 230 centers globally to receive either DB-1303 or investigator's choice single agent chemotherapy (capecitabine, paclitaxel or nab-paclitaxel) until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression (PD), unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials.

This phase II ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting). Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by killing tumor cells. Leucovorin may help the other drugs in the mFOLFOX6 chemotherapy regimen work better by making tumor cells more sensitive to the drugs. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps to stop or slow the spread of tumor cells. Giving binimetinib in combination with mFOLFOX6 chemotherapy may be effective in shrinking or stabilizing advanced biliary tract cancers in the 2nd line setting.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

A phase 2 double-blind, RandomizEd, prospective, placebo controlled STudy of NanO2 TM combined with Radiation and temozolomide in patients with newly-diagnosed glioblastoma multiformE: RESTORE

NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMICRISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

The purpose of this research is to assess the safety, tolerability, pharmacokinetics, and
preliminary antitumor activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors.

The purpose of this research study is to test the safety and possible harms of DB-1311 study drug
when it is given to people at different dose levels. The researchers want to find out what effects
(good and bad) DB-1311 study drug has on you or people with Advanced/Metastatic Solid Tumors.

The purpose of this research study is to evaluate the safety of the experimental antibody/drug called
NEO-201 given in combination with pembrolizumab and test whether it helps shrink your tumor(s).
The experimental drug called NEO-201 (the "study drug") is a monoclonal antibody that is being
tested and is not approved for use in the United States by the FDA. An experimental drug is one
that has not yet been approved for use by the U.S. Food and Drug Administration (FDA).

Pembrolizumab (Keytruda®) is a drug that helps your immune system to fight against your cancer.
It is approved by the FDA for your type of cancer.

Participants with advanced non-small cell lung cancer (NSCLC), head and neck squamous cell
carcinoma (HNSCC), uterine or cervical cancer who have progressed during or after one front-line
standard of care treatment will be enrolled in this study if their tumor has the NEO-201 antigen. You
will be given NEO-201 in combination with pembrolizumab in 6-week cycles. NEO-201 infusion
will be given every 2 weeks and pembrolizumab infusion will be given every 6 weeks.

The purpose of this research is to assess the safety, tolerability, pharmacokinetics, and
preliminary antitumor activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors.

The purpose of this research study is to test the safety and possible harms of DB-1311 study drug
when it is given to people at different dose levels. The researchers want to find out what effects (good and bad) DB-1311 study drug has on you or people with Advanced/Metastatic Solid Tumors.