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NCT04192344 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Neoplasms and Tenosynovial Giant Cell Tumor, sponsored by Abbisko Therapeutics Co.

Recruiting
Registry status
Phase 1
Development phase
276
Enrollment target
17
Study locations

NCT04192344: Recruiting Phase 1 study of Neoplasms and Tenosynovial Giant Cell Tumor, sponsored by Abbisko Therapeutics Co.

NCT04192344 is a Phase 1 study of Neoplasms and Tenosynovial Giant Cell Tumor that is actively recruiting participants, run by Abbisko Therapeutics Co. The registered enrollment target is 276 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (83% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04192344, a Phase 1 study of Neoplasms and Tenosynovial Giant Cell Tumor, is actively recruiting participants, sponsored by Abbisko Therapeutics Co.

RECRUITING
Registry status
Phase 1
Development phase
276 participants
Enrollment target
17
Study locations

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.

Primary Outcome

DLT(dose-limiting toxicity)

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
Abbisko Therapeutics Co

6 total trials

What NCT04192344 shows while recruiting

NCT04192344 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (83% lower).

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.

NCT04192344 lists 17 locations in 14 states (Henan, Jiangsu, Shanghai Municipality).

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.

What interventions are being tested in trial NCT04192344?

The interventions under investigation include: ABSK021 (DRUG).

Who is sponsoring clinical trial NCT04192344?

This trial is sponsored by Abbisko Therapeutics Co, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04192344's enrollment target sits among peer trials

276 35th of 158 higher than 124 of 158 other Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neoplasms 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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Source: ClinicalTrials.gov NCT04192344, the US trial registry maintained by the National Library of Medicine. NCT04192344 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.