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A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )

NCT07417189 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2026-03-11

No results posted yet for this study

Summary

This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.

Conditions

  • Solid Tumors, Adult

Interventions

DRUG

ABSK141-400mg

In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 400mg administration. Thereafter, patients will continuously receive ABSK141 400mg once daily (QD).

DRUG

ABSK141-Recommended Dose for Expansion (RDE)

In the expansion part# patients will orally receive ABSK141 at the recommended dose for expansion (RDE).patients will continuously receive ABSK141 Recommended Dose for Expansion (RDE) once daily (QD).

DRUG

ABSK141-800mg

In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 800mg administration. Thereafter, patients will continuously receive ABSK141 800mg once daily (QD).

DRUG

ABSK141-1200mg

In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 1200mg administration. Thereafter, patients will continuously receive ABSK141 1200mg once daily (QD).

DRUG

ABSK141-Recommended Phase 2 dose (RP2D)

Phase II #patients will orally receive ABSK141 at the Recommended Phase 2 Dose (RP2D).

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Xianjun Yu, Doctor · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2028-12-30
Completion
2029-07-30

Countries

  • China

Study Locations

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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 NCT07417189 on ClinicalTrials.gov