NCT04192344 A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
| NCT ID | NCT04192344 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Abbisko Therapeutics Co, Ltd |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2020-01-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 276 participants in total. It began in 2020-01-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Siqing Fu, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04192344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04192344 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04192344 currently recruiting?
Yes, NCT04192344 is actively recruiting participants. Contact the research team at clinical@abbisko.cn for enrollment information.
Where is the NCT04192344 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Denver, United States, Atlanta, United States, Houston, United States and 11 additional locations.
Who is sponsoring the NCT04192344 clinical trial?
NCT04192344 is sponsored by Abbisko Therapeutics Co, Ltd. The principal investigator is Siqing Fu, MD at M.D. Anderson Cancer Center. The trial plans to enroll 276 participants.