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

NCT05627063 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2025-10-20

No results posted yet for this 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

Interventions

DRUG

ABSK121-NX

In the escalation part, patients will receive a single dose of oral ABSK121-NX on Day -7 followed by a 7-day washout (Day -7 dosing day as 1st day of wash out) as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD) starting at C1D1 and continuing in subsequent cycles (28-day cycles). The starting dose is 3mg QD. In the expansion part, patients will each receive oral ABSK121-NX at the RDE in repeated 28-day cycles.

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Yuan Lu · Wuxi Abbisko Biomedical Technology Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2026-03-15
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05627063 on ClinicalTrials.gov