Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT06882135
Brief Summary:
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.
Detailed Description:
This trial is an open-label, dose-escalation/expansion first-in-human study of HW071021, divided into two phases:
Phase 1 (Dose Escalation): This phase plans to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive oral monotherapy with HW071021 at pre-specified escalating doses (single-dose and continuous-dose administration). The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 in patients. Selected subjects in Phase 1 will undergo a QT/QTc study to assess the drug's effects on QT/QTc intervals and cardiac safety.
Phase 2 (Dose Expansion): This phase intends to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive continuous administration of HW071021 to provide additional clinical data for determining the Phase 2 recommended dose (P2RD) and potential indications.
Study:
NCT06882135
Study Brief:
Protocol Section:
NCT06882135