Trials / Unknown
UnknownNCT05509985
A Phase 1 Study of ASKG315 in Patients With Advanced Solid Tumors
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- AskGene Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 (Part 1) and in combination with pembrolizumab (Part 2) in patients with advanced solid tumors.
Detailed description
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 or ASKG315 combined with pembrolizumab 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. The Part 2 dose escalation consists of 4 planned escalation cohorts. Part 2 of the study will begin enrolling after Part 1 has successfully and safely dosed all patients in the first two cohorts and followed these patients through the entire DLT period. The starting dose of Part 2 will be determined according to the safety and PK of ASKG315 in Part 1 of the study, but in no case will it exceed the highest dose already safely administered in Part 1 and confirmed as tolerable by the Safety Review Committee in Part 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ASKG315 | Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage. |
Timeline
- Start date
- 2023-08-09
- Primary completion
- 2023-09-09
- Completion
- 2024-09-09
- First posted
- 2022-08-22
- Last updated
- 2023-08-14
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT05509985. Inclusion in this directory is not an endorsement.