Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT06882135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HW071021 Monotherapy in Patients With Advanced Solid Tumors
Sponsor:
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Organization:
Study Overview
Official Title:
A Phase I Open-Label, Dose-Escalation and Dose-Expansion Trial Evaluating Safety, Pharmacokinetics, and Efficacy of HW071021 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: