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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

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ClinicalTrials.gov Identifier: NCT04192344
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Abbisko Therapeutics Co, Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: ABSK021 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Experimental: ABSK021
Dose 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.
Drug: ABSK021
ABSK021 oral capsule




Primary Outcome Measures :
  1. Incidence of DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    DLT(dose-limiting toxicity)

  2. Incidence and Severity of AEs [ Time Frame: Through study completion, an average of 6 months ]
    Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. PFS [ Time Frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months ]
    Progression-Free Survival (PFS)

  2. DoR [ Time Frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months ]
    Duration of Response (DoR)

  3. DCR [ Time Frame: 24 weeks post-dose ]
    Disease Control Rate (DCR)

  4. Cmax [ Time Frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose ]
    The peak plasma concentration of a drug after administration

  5. tmax [ Time Frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose ]
    Time to reach Cmax

  6. Bioavailability [ Time Frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose ]
    The systemically available fraction of a drug

  7. Elimination half-life [ Time Frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose ]
    The time required for the concentration of the drug to reach half of its original value



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192344


Contacts
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Contact: Leying Feng +86-21-68912098 ext 8411 leying.feng@abbisko.com
Contact: Siqing Fu, MD (713)792-4318 siqingfu@mdanderson.org

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Munir H Chowdhury    713-792-4976    mchowdhury@mdanderson.org   
Sponsors and Collaborators
Abbisko Therapeutics Co, Ltd
Investigators
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Principal Investigator: Siqing Fu, MD M.D. Anderson Cancer Center
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Responsible Party: Abbisko Therapeutics Co, Ltd
ClinicalTrials.gov Identifier: NCT04192344    
Other Study ID Numbers: ABSK021-101
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No