Tests ABSK021 safety in people with advanced solid tumors

Trial details

Who runs it

Abbisko Therapeutics Co, Ltd

Trial code

NCT04192344

Record updated

9 November 2026

Original 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.Read full original descriptionShow less

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

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.

Inclusion: 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; For Adolescent Cohort (China only):; Patient and/or legally acceptable representative should understand, sign, and date the written voluntary informed consent form prior to screening; Adolescents≥ 12 years of age and < 18 years at the time of informed consent; Body weight ≥ 40kg; A diagnosis of TGCT [including pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT-TS)] (i) that has been histologically confirmed either by local laboratory, and (ii) unresectable, defined as confirmed by assessment by at least two clinical experts (including at least one independent expert who is not part of the trial conduct), meeting one of the following 2 requirements: ①located in a complex anatomical site, is extensively invasive, and cannot be completely resected; ②surgical operation may cause dysfunction or serious complications; Measurable disease as defined by RECIST v1.1 (with at least 1 lesion ≥ 2 cm is required), assessed by MRI scans in local site prior to dosing; Others.

Exclusion: 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; 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); 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; Known allergy or hypersensitivity to any component of the investigational drug product; For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）; Known allergy or hypersensitivity to any component of the investigational drug product; Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R prior to first dosing. However, patients who have received prior treatment with multi-kinase inhibitors that include the CSF-1/CSF-1R pathway are allowed, such as Imatinib and Nilotinib; Known additional malignancy that is progressing or required active treatment within 3 years of the first dose 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; 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; Know additional malignancy that required active treatment and may affect the patient's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ; Active central nervous system (CNS) metastases; Refractory/uncontrolled ascites or pleural effusion; Pregnant or nursing; For patients with tenosynovial giant cell tumor (TGCT) :; Others; For Adolescent Cohort (China only):; Others.

ClinicalTrials.gov NCT04192344