A Phase 1a/b study of NX-1607 in adults with Advanced Malignancies
Research type
Research Study
Full title
A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor, in Adults with Advanced Malignancies, with Phase 1b Expansion in Select Tumor Types
IRAS ID
1003691
Contact name
Robert Brown
Contact email
Eudract number
2021-000616-33
Research summary
This clinical trial studies a study drug called NX-1607. NX-1607 blocks a protein in the cell that can lead to antitumor activity. To determine if NX-1607 is safe for humans and if it affects certain cancers, the study is split into two phases – phase 1a and phase 1b. The phase 1a portion of the study is also known as “dose escalation.” This portion of the study will enroll a small number of patients, between 6 to 60. The purpose of phase 1a is to find a recommended dose of NX-1607 that is safe. The phase 1b portion is also known as “dose expansion.” This portion of the study will help determine if NX-1607 has an effect on the cancers being studied. The phase 1b portion of the study may enroll up to 276 patients. In total, the study can enroll up to around 336 patients.
To take part in the study, the patients will have an advanced cancer and be an adult. These patients may not have treatment options or their treatment no longer works. The type of advanced cancers that these patients have, include epithelial ovarian cancer (EOC), gastric cancer, squamous cell carcinoma of the head and neck (HNSCC), metastatic melanoma, non-small cell lung cancer (NSCLC), metastatic castration resistant prostate cancer (mCRPC), malignant pleural mesothelioma (MPM), triple-negative breast cancer (TNBC), muscle-invasive urothelial cancer, cervical cancer, and microsatellite stable colorectal cancer (MSS CRC) in phase 1a. Phase 1b includes all indications in phase 1a with the addition of diffuse large B-cell lymphoma with Richter transformation (DLBCL-RT).
The duration of the study is anticipated to be around 4 years. Patients that take part in the study will be followed for up to 1 year after they have completed their treatment.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0345
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion