Clinical Trials /

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK021 in Patients With Advanced Solid Tumor

NCT04192344

Description:

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK021 in Patients With Advanced Solid Tumor
  • Official Title: A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: ABSK021-101
  • NCT ID: NCT04192344

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
ABSK021ABSK021

Purpose

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

Detailed Description

      The study will start with a dose escalation part of single-agent ABSK021 administered in
      repeated 28-day cycles in patients with advanced solid for safety and tolerability. The
      expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for
      further evaluating safety and tolerability among selected tumor types. Preliminary antitumor
      activity will also be assessed.
    

Trial Arms

NameTypeDescriptionInterventions
ABSK021ExperimentalDose escalation of oral ABSK021 with a starting dose of 25mg once daily will be guided by"3+3" escalation rules based on safety data until an MTD has been identified or a RDE. For each dose, patients will first receive a single dose ABSK021 tablet(s) by mouth at Day -3 and be followed by a 3-day off as a run-in period to access the safety and PK of single-dose. Then, patients will continuously receive ABSK021 once daily (QD) in repeated 28-day cycles.
  • ABSK021

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed solid tumors that have progressed on or intolerant to
             standard therapy or whom no standard therapy exists

          -  ECOG (electrocorticogram) performance status 0~1

          -  Life expectancy ≥ 3 months

          -  Adequate organ function and bone marrow function

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to any component of the investigational drug product
             Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating
             factor 1 receptor) pathway inhibitors

          -  Known additional malignancy that is progressing or required active treatment within 3
             years of the first dose of study treatment

          -  Inability to take oral medication or significant nausea and vomiting, malabsorption,
             external biliary shunt, or significant bowel resection that would preclude adequate
             absorption of oral medication

          -  Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy
             or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter)
             prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin
             should be 6 weeks prior to initiation of study treatment)

          -  Major surgery within 4 weeks of the first dose of study drug and all surgical wounds
             must be healed and free of infection or dehiscence

          -  Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies,
             including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with
             the exception of alopecia and vitiligo

          -  Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first
             dose of study drug

          -  Concomitant use of strong inhibitors or inducers of CYP3A4

          -  Active central nervous system (CNS) metastases

          -  Impaired cardiac function or clinically significant cardiac disease

          -  Patients with Gilbert's Syndrome or other underlying conditions that may lead to a
             greater likelihood of developing LFT(liver function test) abnormalities during the
             study

          -  Known human immunodeficiency virus or active hepatitis B, or active hepatitis C
             infection

          -  Refractory/uncontrolled ascites or pleural effusion

          -  Pregnant or nursing
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of DLTs
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:DLT(dose-limiting toxicity)

Secondary Outcome Measures

Measure:PFS
Time Frame:From date of enrollment until the date of first documented progression or death, assessed up to 12 months
Safety Issue:
Description:Progression-Free Survival (PFS)
Measure:DoR
Time Frame:From date of enrollment until the date of first documented progression or death, assessed up to 12 months
Safety Issue:
Description:Duration of Response (DoR)
Measure:DCR
Time Frame:24 weeks post-dose
Safety Issue:
Description:Disease Control Rate (DCR)
Measure:Cmax
Time Frame:Pre-dose and multiple timepoints (up to 72 hours) post-dose
Safety Issue:
Description:The peak plasma concentration of a drug after administration
Measure:tmax
Time Frame:Pre-dose and multiple timepoints (up to 72 hours) post-dose
Safety Issue:
Description:Time to reach Cmax
Measure:Bioavailability
Time Frame:Pre-dose and multiple timepoints (up to 72 hours) post-dose
Safety Issue:
Description:The systemically available fraction of a drug
Measure:Elimination half-‍life
Time Frame:Pre-dose and multiple timepoints (up to 72 hours) post-dose
Safety Issue:
Description:The time required for the concentration of the drug to reach half of its original value

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Abbisko Therapeutics Co, Ltd

Last Updated

July 10, 2020