A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: WGI-0301

• Registration Number: NCT05267899
• Lead Sponsor: Zhejiang Haichang Biotech Co., Ltd.

Brief Summary

The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors.

The study is also done to learn how the study drug is taken up by your body; this is called Pharmacokinetic (PK) studies and how the study drug affects the body; this is called Pharmacodynamics (PD)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-07
• Study Start: 2022-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26
• Primary Completion: 2024-10-15
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WGI-0301	WGI-0301	-

Primary Outcome Measures

Name	Time	Method
Recommended Phase 2 Dose of WGI-0301	Approximately 16 months	Based on dose-limiting toxicities, the maximal tolerated dose and all other available safety, pharmacokinetic/pharmacodynamic data as assessed by the cohort review committee
Safety and tolerability	Approximately 16 months	Incidence and severity of treatment-related adverse events and serious adverse events

Secondary Outcome Measures

Name	Time	Method
Half-life	Approximately 16 months	Plasma concentration half-life of WGI-0301
Maximum plasma concentration	Approximately 16 months	Highest observed plasma concentration of WGI-0301
Area under the curve	Approximately 16 months	Area under the plasma concentration time curve of WGI-0301
Time of maximum plasma concentration	Approximately 16 months	Time to reach highest observed plasma concentration of WGI-0301

Trial Locations

Locations (3)

Valkyrie Clinical Trials; 🇺🇸 Los Angeles, California, United States

The Oncology Institute of Hope and Innovation; 🇺🇸 Whittier, California, United States

University of Maryland, Greenebaum Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States