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

Primary Purpose

Neoplasms, Tenosynovial Giant Cell Tumor

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABSK021
Sponsored by
Abbisko Therapeutics Co, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Tenosynovial Giant Cell Tumor, TGCT, Solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

For patients with tenosynovial giant cell tumor (TGCT) :

  1. A diagnosis of TGCT [i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);
  2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
  3. Others

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

For patients with tenosynovial giant cell tumor (TGCT) :

  1. Known allergy or hypersensitivity to any component of the investigational drug product
  2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US)
  3. Others

Sites / Locations

  • Precision NextGen OncologyRecruiting
  • SCRI at HealthOne
  • The Winship Cancer Institute of Emory University
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABSK021

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of DLTs
DLT(dose-limiting toxicity)
Incidence and Severity of AEs
Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)

Secondary Outcome Measures

PFS
Progression-Free Survival (PFS)
DoR
Duration of Response (DoR)
DCR
Disease Control Rate (DCR)
Cmax
The peak plasma concentration of a drug after administration
tmax
Time to reach Cmax
Bioavailability
The systemically available fraction of a drug
Elimination half-life
The time required for the concentration of the drug to reach half of its original value

Full Information

First Posted
November 27, 2019
Last Updated
October 16, 2023
Sponsor
Abbisko Therapeutics Co, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04192344
Brief Title
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbisko Therapeutics Co, Ltd

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Tenosynovial Giant Cell Tumor
Keywords
Tenosynovial Giant Cell Tumor, TGCT, Solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABSK021
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABSK021
Intervention Description
ABSK021 oral capsule
Primary Outcome Measure Information:
Title
Incidence of DLTs
Description
DLT(dose-limiting toxicity)
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Title
Incidence and Severity of AEs
Description
Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-Free Survival (PFS)
Time Frame
From date of enrollment until the date of first documented progression or death, assessed up to 12 months
Title
DoR
Description
Duration of Response (DoR)
Time Frame
From date of enrollment until the date of first documented progression or death, assessed up to 12 months
Title
DCR
Description
Disease Control Rate (DCR)
Time Frame
24 weeks post-dose
Title
Cmax
Description
The peak plasma concentration of a drug after administration
Time Frame
Pre-dose and multiple timepoints (up to 72 hours) post-dose
Title
tmax
Description
Time to reach Cmax
Time Frame
Pre-dose and multiple timepoints (up to 72 hours) post-dose
Title
Bioavailability
Description
The systemically available fraction of a drug
Time Frame
Pre-dose and multiple timepoints (up to 72 hours) post-dose
Title
Elimination half-life
Description
The time required for the concentration of the drug to reach half of its original value
Time Frame
Pre-dose and multiple timepoints (up to 72 hours) post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 For patients with tenosynovial giant cell tumor (TGCT) : A diagnosis of TGCT [i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board); Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans; Others 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 For patients with tenosynovial giant cell tumor (TGCT) : Known allergy or hypersensitivity to any component of the investigational drug product For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US) Others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YUAN LU
Phone
+86-21-68910052
Email
clinical@abbisko.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Siqing Fu, MD
Phone
(713)792-4318
Email
siqingfu@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Precision NextGen Oncology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamlesh Sankhala, MD
Email
info@nextgenonc.com
Phone
1-424-777-0708
Facility Name
SCRI at HealthOne
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1238
Country
United States
Individual Site Status
Completed
Facility Name
The Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Completed
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this trial

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

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