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NCT05627063 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors

A Phase 1 study of Solid Tumor, sponsored by Abbisko Therapeutics Co.

Active
Registry status
Phase 1
Development phase
169
Enrollment target
20
Study locations

NCT05627063 is a Phase 1 study of Solid Tumor that is active but no longer recruiting, run by Abbisko Therapeutics Co. The registered enrollment target is 169 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT05627063, a Phase 1 study of Solid Tumor, is active but no longer recruiting, sponsored by Abbisko Therapeutics Co.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
169 participants
Enrollment target
20
Study locations

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

Solid Tumor

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

FieldValue
Enrollment Target 169 participants
Start Date 2023-06-26
Est. Completion 2026-06-30
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 NCT05627063

The ClinicalTrials.gov registry entry for NCT05627063 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (24% lower). The listed sponsor is Abbisko Therapeutics Co, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT05627063 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Henan, Sichuan, Other.

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.

What interventions are being tested in trial NCT05627063?

The interventions under investigation include: ABSK121-NX (DRUG).

Who is sponsoring clinical trial NCT05627063?

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

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

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