Phase 12 Study of D3S-002 Alone or With D3S-001 for Adults With Advanced Solid Tumors Having MAPK Pathway Mutations

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and recommended phase 2 dose of D3S-002 given orally in adult patients with advanced solid tumors that have mutations in the mitogen-activated protein kinase MAPK pathway. This first-in-human study includes different parts assessing D3S-002 alone or combined with D3S-001 in patients with specific tumor types, including non-small cell lung cancer without certain genetic mutations. The study has two main parts Part 1 is a dose escalation phase where D3S-002 is given orally alone. Part 2 includes a dose escalation phase and a dose expansion phase where participants receive both D3S-002 and D3S-001 orally. Treatments are given in 21-day cycles, and doses are adjusted to find the recommended phase 2 dose. Participants will be monitored from the first dose up to 24 months, with assessments including adverse events, dose-limiting toxicities, and pharmacokinetic measurements such as drug concentrations in the blood. Tumor response will also be evaluated using standardized criteria. Safety, tolerability, and effectiveness measurements will be collected throughout the study, and participants may be followed for up to two years after starting treatment.

A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations