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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors
NCT05627063 · 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 ABSK121-NX administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK121-NX 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 ABSK121-NX
Study Locations (20)
Henan
- The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Sichuan
- West China School of Medicine/West China Hospital of Sichuan University — Chengdu
- Mianyang Central Hospital — Mianyang
Other
- Fujian Cancer Hospital (Department of Hepatobiliary and Pancreatic Oncology /Phase I Ward) — Fuzhou
- Harbin Medical University Cancer Hospital (Gastroenterology Department 2nd Ward) — Haerbin
California
- UC San Diego Moores Cancer Center — La Jolla
Michigan
- Karmanos Cancer Institute — Detroit
Nevada
- Comprehensive Cancer Centers of Nevada — Las Vegas
Ohio
- Gabrail Cancer Center Research — Canton
Chongqing Municipality
- Chongqing University Cancer Hospital — Chongqing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05627063
The ClinicalTrials.gov registry entry for NCT05627063 describes a study currently listed as active not 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 169 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 ABSK121-NX 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: NCT05627063 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Henan, Sichuan, Other. 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 NCT05627063 about?
NCT05627063 is a clinical study titled "A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX 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 ABSK121-NX administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK121-NX at the rec...
What is the current status of trial NCT05627063?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 169 participants. The study started on 2023-06-26. Estimated completion is 2026-06-30.
What conditions does trial NCT05627063 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 NCT05627063?
The interventions under investigation include: ABSK121-NX (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05627063?
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 NCT05627063 being conducted?
This trial has 20 study locations across California, Michigan, Nevada, Ohio, Chongqing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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