Study of ABSK061 for Advanced Solid Tumors
This study is testing a new drug called ABSK061 in people with advanced solid tumors. The main goals are to understand how safe ABSK061 is, how well your body tolerates it, and how it moves through your body. You might be able to join if you have a solid tumor that has grown despite standard treatments, or if there are no standard treatments available for you. The study will start by giving different doses of ABSK061 to a small group of people to find the safest and most effective dose. Once that dose is found, more people will receive ABSK061 to further check its safety and see if it has any anti-tumor effects. This study is for adults aged 18 and older.
- Study design
- This is an open-label Phase 1 study, meaning both you and your doctors will know you are receiving ABSK061. It plans to enroll 85 participants.
- What's involved
- You will receive ABSK061 by mouth, initially once on the first day of the first cycle, then twice daily for the rest of that cycle and in future cycles. Each cycle lasts 28 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored through study completion, which is expected to be an average of half a year.
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NCT05244551
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentAbbisko Therapeutics Co, Ltd
~85 participants
Updated 2024-08-12 on ClinicalTrials.gov
What's tested:ABSK061
At a glance
Recruiting sites
12 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of DLT
Measured over At the end of Cycle 1 (each cycle is 28 days)
+1 more outcome measured
Conditions
Where it's being run
22 sites across 19 statesHenan2
Jilin2
Liaoning2
Texas1
Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 5151
Anhui1
Beijing Municipality1
Chongqing Municipality1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure
Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF \>470 ms or history of long QT interval corrected (QTc) syndrome (Note: QTc interval corrected by Fridericia's formula).
Left ventricular ejection fraction (LVEF) \<50% or below the institutional lower limit of normal (whichever is higher) 11. Known human immunodeficiency virus (HIV) or active hepatitis B, or active hepatitis C infection; positive tests for hepatitis B virus surface antigen (HBsAg), or antibody to hepatitis B core Ag (HBcAb), or hepatitis C RNA in serum (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction (PCR) test are allowed; positive tests for HBV HBsAg or HBcAb with HBV-DNA measurements lower than 1000IU/ml can be included) 12. Any of the following ophthalmological criteria:
Current evidence or previous history of retinal pigmented epithelial detachment (RPED)
Previous laser treatment or intra-ocular injection for treatment of macular degeneration
Current evidence or previous history of dry or wet age-related macular degeneration
Current evidence or previous history of retinal vein occlusion (RVO)
Current evidence or previous history of retinal degenerative diseases (eg, hereditary)
Current evidence or previous history of any other clinically relevant chorioretinal defect
Current evidence or previous history of corneal pathology such as conjunctivitis, keratopathy, corneal abrasion or ulceration 13. Patients with refractory/uncontrolled ascites or pleural effusion. 14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug. 15. Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study and for up to 6 months after the last dose of study drug. 16. Sexually active males, unless they use a condom during intercourse while taking drug and for 5 consecutive compound half-lives plus 60 days after stopping study drug, should not father a child. A condom is required to be used also by vasectomized men to prevent delivery of the drug via seminal fluid. 17. Vaccination with a live, attenuated vaccine within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines). 18. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
What this trial measures
- Incidence of DLTAt the end of Cycle 1 (each cycle is 28 days)
dose-limiting toxicities (DLTs)
- Incidence and severity of adverse events (AEs)Through study completion, an average of half year
adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)