Recruiting
Phase 1

ABSK-021

Sponsor:

Abbisko Therapeutics Co, Ltd

Code:

NCT04192344

Conditions

Neoplasms

Tenosynovial Giant Cell Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABSK021

Study Details

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.

Conditions

Neoplasms

Tenosynovial Giant Cell Tumor

Study ID

NCT04192344

Start date

Jan 20, 2020

Status verified date

Aug, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

276 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

ABSK021

ABSK021 oral capsule

Primary outcome measure

  • Incidence of DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
  • Incidence and Severity of AEs [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Locations

Precision NextGen Oncology

Recruiting

Beverly Hills, California, United States, 90212

Contacts

More Information

Sponsor

Abbisko Therapeutics Co, Ltd

Last update posted

May 22, 2025

Last verified

Aug, 2024

Keywords

  • Tenosynovial Giant Cell Tumor
  • TGCT
  • Solid tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbisko Therapeutics Co, Ltd on 2025-05-22.