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

NCT04192344 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ABSK021-101
• Study Type: interventional
• Target: 276
• Locations: 2 countries
• Sites: 17

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

Keywords

Tenosynovial Giant Cell Tumor; TGCT; Solid tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of DLTs

  DLT(dose-limiting toxicity)

  At the end of Cycle 1 (each cycle is 28 days)

• Incidence and Severity of AEs

  Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)

  Through study completion, an average of 6 months

Secondary Outcomes (7)

• PFS

  From date of enrollment until the date of first documented progression or death, assessed up to 12 months

• DoR

  From date of enrollment until the date of first documented progression or death, assessed up to 12 months

• DCR

  24 weeks post-dose

• Cmax

  Pre-dose and multiple timepoints (up to 72 hours) post-dose

• tmax

  Pre-dose and multiple timepoints (up to 72 hours) post-dose

Study Arms (1)

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.

Drug: ABSK021

Interventions

ABSK021 DRUG

ABSK021 oral capsule

ABSK021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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) :

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (17)

Precision NextGen Oncology

Beverly Hills, California, 90212, United States

ACTIVE NOT 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

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangzhou, China

RECRUITING

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

COMPLETED

Henan Cancer Hospital

Zhengzhou, Henan, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Zhengzhou Universtity

Zhengzhou, Henan, China

COMPLETED

Jiangsu Province Hospital

Nanjing, Jiangsu, China

ACTIVE NOT RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

ACTIVE NOT RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

COMPLETED

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

COMPLETED

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

COMPLETED

Xi'an Hong Hui Hospital

Xian, Shanxi, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Giant Cell Tumor of Tendon Sheath

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Synovitis; Joint Diseases; Musculoskeletal Diseases; Tendinopathy; Muscular Diseases

Study Officials

• Siqing Fu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YUAN LU

CONTACT

+86-21-68910052; clinical@abbisko.cn

Siqing Fu, MD

CONTACT

(713)792-4318; siqingfu@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 10, 2019
• Study Start: January 20, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (4); CN (13)