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A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors

NCT07288957 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2025-12-17

No results posted yet for this study

Summary

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

Conditions

  • Solid Tumors (Phase 1)

Interventions

DRUG

ABSK131

In the escalation part，patients will first orally receive a single dose of ABSK131 on D-2, followed by a two-day run-in period to assess the PK profile of single-dose ABSK131 administration. Thereafter, patients will continuously receive ABSK131 once daily (QD). In the expansion part， patients will orally receive ABSK131 at the recommended dose for expansion (RDE)

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2028-12-30
Completion
2029-07-30
FDA Drug
Yes

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 NCT07288957 on ClinicalTrials.gov