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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors

NCT05244551 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-08-12

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 ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 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

ABSK061

In the escalation part, patients will receive a single dose of oral ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in subsequent cycles (28-day cycles). The starting dose is 5 mg BID. In the expansion part, patients will each receive oral ABSK061 at the RDE in repeated 28-day cycles.

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
2022-06-30
Primary Completion
2025-04-30
Completion
2025-04-30
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 NCT05244551 on ClinicalTrials.gov