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

Last updated: May 20, 2025
Sponsor: Abbisko Therapeutics Co, Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ABSK021

Clinical Study ID

NCT04192344
ABSK021-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed solid tumors that have progressed on or intolerant tostandard 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 giantcell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmedeither by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worseningfunctional limitation or severe morbidity (locally advanced disease), with morbiditydetermined consensually by qualified personnel (eg, two surgeons or a multidisciplinary tumor board);

  2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm isrequired), assessed from MRI scans;

  3. Others

Exclusion

Exclusion Criteria:

  • Known allergy or hypersensitivity to any component of the investigational drugproduct Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colonystimulating 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 adequateabsorption of oral medication

  • Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrinetherapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever isshorter) prior to initiation of study treatment (chemotherapy with nitrosourea ormitomycin 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 woundsmust 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 thefirst 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 agreater likelihood of developing LFT(liver function test) abnormalities during thestudy

  • Known human immunodeficiency virus or active hepatitis B, or active hepatitis Cinfection

  • 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 drugproduct

  2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (notapplicable for TGCT patients in US)

  3. Others

Study Design

Total Participants: 276
Treatment Group(s): 1
Primary Treatment: ABSK021
Phase: 1
Study Start date:
January 20, 2020
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Beijing Jishuitan Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangdong, Guangzhou
    China

    Active - Recruiting

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei
    China

    Completed

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou Universtity

    Zhengzhou, Henan
    China

    Completed

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning
    China

    Completed

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai
    China

    Completed

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai
    China

    Completed

  • Xi'an Hong Hui Hospital

    Xian, Shanxi
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Precision NextGen Oncology

    Beverly Hills, California 90212
    United States

    Active - Recruiting

  • SCRI at HealthOne

    Denver, Colorado 80218-1238
    United States

    Completed

  • The Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Completed

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Completed

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