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NCT05287399 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Ascletis Pharmaceuticals Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 4
- Study locations
NCT05287399: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Ascletis Pharmaceuticals Co..
NCT05287399 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Ascletis Pharmaceuticals Co.. The registered enrollment target is 18 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05287399, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Ascletis Pharmaceuticals Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.
Primary Outcome
The primary endpoint of this study is the proportion of the patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following treatment of PD1-PDL1 inhibitor
Conditions Studied
Interventions
- DRUG ASC61 200 mg 1
- DRUG ASC61 200 mg 2
- DRUG ASC61 300 mg
- DRUG ASC61 400 mg
- DRUG ASC61 600 mg
Study Locations (4)
California
- California Cancer Associates for Research & Excellence (cCARE) - Encinitas
- California Cancer Associates for Research & Excellence (cCARE) - Fresno
- California Cancer Associates for Research & Excellence (cCARE) - San Marcos
Nebraska
- Nebraska Cancer Specialists - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2025-01-17 |
| Phase | Phase 1 |
What the finished NCT05287399 record still lists
NCT05287399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which ASC61 200 mg 1 is the first listed.
NCT05287399 reports a single indexed study location in California, Nebraska.
Frequently Asked Questions
What is clinical trial NCT05287399 about?
NCT05287399 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors". This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanc...
What is the current status of trial NCT05287399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-08-02. Estimated completion is 2025-01-17.
What conditions does trial NCT05287399 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT05287399?
The interventions under investigation include: ASC61 200 mg 1 (DRUG), ASC61 200 mg 2 (DRUG), ASC61 300 mg (DRUG), ASC61 400 mg (DRUG), ASC61 600 mg (DRUG).
Who is sponsoring clinical trial NCT05287399?
This trial is sponsored by Ascletis Pharmaceuticals Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05287399 being conducted?
This trial has 4 study locations across California, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05287399's enrollment target sits among peer trials
18 128th of 144 higher than 15 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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