Phase 1 Study of D3S-003 Oral Treatment in Adults With Advanced Solid Tumors Carrying KRAS p.G12D Mutation

What this Trial Is About

Researchers are evaluating D3S-003, an oral drug, in a first-in-human Phase 1 trial for people with advanced solid tumors that have a KRAS p.G12D mutation. This open-label, multicenter study aims to assess the drugs safety, tolerability, how the body processes it, and early signs of effectiveness in this group of patients who have already tried standard therapies without success or for whom standard options are unsuitable. The trial includes two parts of dose escalation Part 1a with once daily dosing and Part 1b with twice daily dosing of D3S-003. Participants will receive the drug orally, and the study will determine the maximum tolerated dose and recommended Phase 2 dose by monitoring dose-limiting toxicities over cycles lasting 21 days each. This trial will continue for up to approximately 7 months, with the dose adjusted to evaluate safety and preliminary efficacy. Participants will be closely monitored from screening through treatment and up to 30 days after the last dose for adverse events. Assessments include measuring drug levels in the blood at various times, evaluating tumor response according to RECIST v1.1 criteria, and tracking progression-free survival. The study is sponsored by D3 Bio Wuxi Co., Ltd and will last until January 2028, with participants undergoing regular evaluations to ensure their safety and to measure how well the drug works against their tumors.

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.