NCT05627063

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

A Phase 1, Open-Label Study of ABSK121-NX to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 169 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Escalation Part: Dose escalation of oral ABSK121-NX will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK121 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) beginning at C1D1. The dose escalation will start at 3 mg QD followed by dose escalation of a total of 8 potential dose levels. Once RDE is determined, an RDE-confirmation group of up to 24 more patients may be enrolled at the selected dose levels to further evaluate safety and efficacy (up to 12 per dose level/regimen), if approved by the sponsor. In addition, a preliminary food-effect (FE) may be evaluated in Cycle 1 D15 or later in at least 6 patients from the RDE- confirmation part. After the RDE is determined in the dose escalation part, the dose expansion phase will be conducted. Expansion Part: When health authorities outside US require that the safety data in the local population be provided prior to the expansion part, a minimum of 3 local subjects will be enrolled and treated at the selected RDE dose level first in that country/region to evaluate the tolerability of ABSK121-NX. The inclusion and exclusion criteria for escalation part will apply for these subjects. After similar safety and tolerability of ABSK121-NX in patients in the relevant locality have been confirmed by local Investigators and the Sponsor, additional patients will be allowed to enroll in the expansion part.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-03-15
• Completion: 2026-06-30
• First posted: 2022-11-25
• Last updated: 2025-10-20

Locations

24 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study