Phase 1 Study of NX-1607, an Oral CBL-B Inhibitor, in Adults With Advanced Cancers Including Ovarian, Gastric, Head and Neck, Melanoma, Lung, Prostate, Breast, Urothelial, Cervical, Colorectal, and Lymphoma Dose Escalation and Expansion With or Without Paclitaxel Combination

What this Trial Is About

Researchers are evaluating NX-1607, a CBL-B inhibitor, in adults with advanced malignancies that have no effective standard treatments or for whom standard therapies are no longer suitable. This first-in-human Phase 1a1b study aims to assess the safety, tolerability, and anti-cancer activity of NX-1607 in various solid tumors and lymphomas. The study is open-label and includes multiple cancer types such as ovarian, gastric, lung, prostate, breast, and colorectal cancers, among others. The study has two main phases Phase 1a focuses on dose escalation to find safe and tolerable doses of NX-1607 used alone or in combination with paclitaxel. Phase 1a includes evaluation of multiple dosing levels and the effect of food on NX-1607. Phase 1b expands treatment at selected doses in specific cancers, either as monotherapy or combined with paclitaxel. Treatment involves oral NX-1607 and intravenous paclitaxel, with separate cohorts for different tumor types and dosing regimens. Participants will undergo regular assessments including safety monitoring for adverse events, immune-related effects, and dose-limiting toxicities for up to two years. Effectiveness will be measured by tumor response rates and progression-free survival over up to three years. Additional evaluations include blood tests for drug levels and biomarkers, tissue biopsies, and survival tracking. The study requires consent and adherence to protocol restrictions, with ongoing safety and efficacy monitoring throughout the study period.

A Study of NX-1607 in Adults With Advanced Malignancies