AskGene Pharma, Inc.
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent in patients with advanced solid tumors.
Advanced Solid Tumors
ASKG315
Phase 1
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg.
Study Type : | Interventional |
Estimated Enrollment : | 56 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors. |
Actual Study Start Date : | October 15, 2022 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | October 31, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: ASKG315 Single or multiple ascending dose of ASKG315 |
Biological: ASKG315 |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China,
Recruiting
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China,
Recruiting
Shandong cancer hospital
Jinan, Shandong, China,
Recruiting
Shanghai East Hospital
Shanghai, Shanghai, China,