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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 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.

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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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2022-08-02
Est. Completion 2025-01-17
Phase Phase 1

Sponsor

Ascletis Pharmaceuticals Co.

1 total trials

What the Registry Record Tells You About NCT05287399

The ClinicalTrials.gov registry entry for NCT05287399 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower). The listed sponsor is Ascletis Pharmaceuticals Co., which has 1 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.