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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
ABSK021-101
- NCT ID:
NCT04192344
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ABSK021 | | ABSK021 |
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
Name | Type | Description | Interventions |
---|
ABSK021 | Experimental | 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. | |
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
June 9, 2021