RECRUITING

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

Conditions

Neoplasms Tenosynovial Giant Cell Tumor TGCT Solid tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

Quick Facts

Study Start:2020-01-20

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04192344

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	* 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 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

Inclusion Criteria

Exclusion 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
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

* 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
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

Contacts and Locations

Study Contact

YUAN LU

CONTACT

+86-21-68910052

clinical@abbisko.cn

Siqing Fu, MD

CONTACT

(713)792-4318

siqingfu@mdanderson.org

Principal Investigator

Siqing Fu, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

Precision NextGen Oncology

Beverly Hills, California, 90212

United States

SCRI at HealthOne

Denver, Colorado, 80218-1238

United States

The Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Abbisko Therapeutics Co, Ltd

Siqing Fu, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-20

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-01-20

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Tenosynovial Giant Cell Tumor
TGCT
Solid tumors

Additional Relevant MeSH Terms

Neoplasms
Tenosynovial Giant Cell Tumor