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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
NCT05244551 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Conditions Studied
Interventions
- DRUG ABSK061
Study Locations (20)
Henan
- Henan Cancer Hospital — Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Jilin
- First Hospital of Jilin University — Changchun
- JILIN Cancer Hospital — Changchun
Liaoning
- Liaoning Province Cancer Hospital — Shenyang
- The First Hospital of China Medical University — Shenyang
Texas
- Mary Crowley Cancer Research — Dallas
Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515
- Yuan LU — Shanghai
Anhui
- The First Affiliated Hospital of Bengbu Medical College — Bengbu
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Chongqing Municipality
- Chongqing Daping Hospital — Chongqing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05244551
The ClinicalTrials.gov registry entry for NCT05244551 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbisko Therapeutics Co, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which ABSK061 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05244551 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Henan, Jilin, Liaoning. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05244551 about?
NCT05244551 is a clinical study titled "A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors". This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommend...
What is the current status of trial NCT05244551?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2022-06-30. Estimated completion is 2025-04-30.
What conditions does trial NCT05244551 study?
This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05244551?
The interventions under investigation include: ABSK061 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05244551?
This trial is sponsored by Abbisko Therapeutics Co, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05244551 being conducted?
This trial has 20 study locations across Texas, Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Anhui, Beijing Municipality, Chongqing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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