A Phase 1/2 Study Evaluating Safety, Dosing, and Pharmacokinetics of Oral D3S-002 Alone or With D3S-001 in Adults With Advanced Solid Tumors Having MAPK Pathway Mutations

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and appropriate dosing of D3S-002 in adults with advanced solid tumors that have mutations in the MAPK pathway. This first-in-human study aims to find the recommended phase 2 dose of D3S-002 given daily by mouth in 21-day cycles. The study includes adults with metastatic or locally advanced solid tumors or non-small cell lung cancer with specific genetic mutations and prior treatment history. The study has two main parts: Part 1 involves dose escalation of D3S-002 given orally as a single drug. Part 2a also involves dose escalation but tests D3S-002 together with another oral drug, D3S-001. Part 2b is a dose expansion phase where the combination of D3S-002 and D3S-001 is further evaluated. Both drugs are taken by mouth, and participants receive treatment cycles lasting 21 days each. Participants will be monitored for adverse events starting from the first dose until 30 days after their last dose, with ongoing assessments up to 24 months. Researchers will measure drug levels in the blood, responses to treatment using specific tumor evaluation criteria, and progression-free survival. Safety, tolerability, and pharmacokinetics are closely tracked throughout the study. Participants must adhere to study visits and provide tumor and blood samples for genetic analysis when required.

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