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RECRUITING Phase 1

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

NCT04192344 · View on ClinicalTrials.gov ↗

Study Summary

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

Interventions

  • DRUG ABSK021

Study Locations (17)

Henan

  • Henan Cancer Hospital — Zhengzhou
  • The First Affiliated Hospital of Zhengzhou Universtity — Zhengzhou

Jiangsu

  • Jiangsu Province Hospital — Nanjing
  • Nanjing Drum Tower Hospital — Nanjing

Shanghai Municipality

  • Huashan Hospital of Fudan University — Shanghai
  • Shanghai Sixth People's Hospital — Shanghai

California

  • Precision NextGen Oncology — Beverly Hills

Colorado

  • SCRI at HealthOne — Denver

Georgia

  • The Winship Cancer Institute of Emory University — Atlanta

Texas

  • MD Anderson Cancer Center — Houston

Beijing Municipality

  • Beijing Jishuitan Hospital — Beijing

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2020-01-20
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Abbisko Therapeutics Co

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04192344

The ClinicalTrials.gov registry entry for NCT04192344 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 276 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 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which ABSK021 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: NCT04192344 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Henan, Jiangsu, Shanghai Municipality. 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 NCT04192344 about?

NCT04192344 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor". This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

What is the current status of trial NCT04192344?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 276 participants. The study started on 2020-01-20. Estimated completion is 2026-12-31.

What conditions does trial NCT04192344 study?

This clinical trial studies the following conditions: Neoplasms, Tenosynovial Giant Cell 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 NCT04192344?

The interventions under investigation include: ABSK021 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04192344?

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 NCT04192344 being conducted?

This trial has 17 study locations across California, Colorado, Georgia, Texas, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial