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

NCT ID: NCT04192344

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2026-12-31

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.

Conditions

Neoplasms; Tenosynovial Giant Cell Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ABSK021

Intervention Type: DRUG

ABSK021 oral capsule

Interventions

ABSK021

ABSK021 oral capsule

Intervention Type: DRUG

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) :

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbisko Therapeutics Co, Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siqing Fu, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Precision NextGen Oncology

Beverly Hills, California, United States

Site Status: RECRUITING

SCRI at HealthOne

Denver, Colorado, United States

Site Status: COMPLETED

The Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status: COMPLETED

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: COMPLETED

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangzhou, China

Site Status: RECRUITING

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Site Status: COMPLETED

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

The First Affiliated Hospital of Zhengzhou Universtity

Zhengzhou, Henan, China

Site Status: COMPLETED

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status: ACTIVE_NOT_RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status: COMPLETED

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: COMPLETED

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: COMPLETED

Xi'an Hong Hui Hospital

Xian, Shanxi, China

Site Status: RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

United States; China

Central Contacts

YUAN LU

Role: CONTACT

clinical@abbisko.cn

+86-21-68910052

Siqing Fu, MD

Role: CONTACT

siqingfu@mdanderson.org

(713)792-4318

Facility Contacts

Kamlesh Sankhala, MD

Role: primary

info@nextgenonc.com

Role: backup

1-424-777-0708

Xiaohui Niu, MD

Role: primary

Jingnan Shen, MD

Role: primary

Weitao Yao, MD

Role: primary

Rutian Li, MD

Role: primary

Zhichao Tong, MD

Role: primary

Yong Zhou, MD

Role: primary

Zhaoming Ye, MD

Role: primary

Other Identifiers

ABSK021-101

Identifier Type: -

Identifier Source: org_study_id