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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female age 18 years or older
Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥ 100×109/L without transfusion requirement within 14 days before 1st dose, Hemoglobin (Hb)≥90 g/L, Total bilirubin (TBIL) ≤1×ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN, Serum creatinine (Cr) of ≤1.5×ULN for the reference laboratory or creatinine clearance (Crcl) ≥ 50 mL/min based on Cockcroft-Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the study completion, an average of half year
Awards & highlights
Study Summary
This trialtests a new drug to treat advanced solid tumors, looking at safety, tolerability, and effectiveness.
Who is the study for?
This trial is for adults with advanced solid tumors, specifically urothelial carcinoma or cholangiocarcinoma that's worsened despite treatment or when no standard treatment exists. Participants must have measurable lesions, a life expectancy of at least 3 months, and certain genetic alterations in their tumors. They need good organ function and can't be part of the trial if they've had recent major surgery, untreated brain metastases, active hepatitis or HIV infections, heart problems, eye diseases affecting the retina or cornea, uncontrolled fluid accumulation in the body cavities, are pregnant/nursing or unwilling to use effective contraception.Check my eligibility
What is being tested?
The study tests ABSK061 given orally over repeated 28-day cycles to see how safe it is and how well patients tolerate it. It starts with dose escalation to find an appropriate dose level followed by expansion at this recommended dose among selected tumor types while also checking preliminary effects on tumor size.See study design
What are the potential side effects?
While specific side effects aren't listed here as this is a Phase I trial primarily assessing safety and tolerability of ABSK061 in humans for the first time; potential side effects could include typical reactions such as nausea, fatigue, allergic responses to medication components and possibly others depending on individual patient response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My blood tests meet the required levels for the study.
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I am fully active or can carry out light work.
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My cancer has worsened or I can't tolerate standard treatments, and no other options are available.
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I have urothelial carcinoma or cholangiocarcinoma and standard treatments haven’t worked or aren’t suitable for me.
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My tumor has specific FGFR2/3 genetic changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of half year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of half year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events (AEs)
Incidence of DLT
Secondary outcome measures
AUC
AUCss
CL/F
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ABSK061Experimental Treatment1 Intervention
Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed.
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Who is running the clinical trial?
Abbisko Therapeutics Co, LtdLead Sponsor
18 Previous Clinical Trials
1,218 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I cannot take pills due to severe nausea, vomiting, or issues with my digestive system.My blood tests meet the required levels for the study.I have another cancer that is getting worse or needs treatment.I have uncontrolled fluid buildup in my abdomen or around my lungs.I do not have active HIV, hepatitis B, or hepatitis C.I have previously been treated with FGFR inhibitors for my condition.I am willing to have a biopsy if my previous cancer tissue samples are not usable.I have not had major surgery in the last 4 weeks and my surgical wounds are healed.I have not consumed grapefruit, pomegranates, or similar fruits, nor taken drugs that interact with other medications in the last 7 days.I am a man who will use a condom during the study and for some time after, to prevent drug exposure through semen.I am fully active or can carry out light work.My cancer has worsened or I can't tolerate standard treatments, and no other options are available.I have a history of significant eye problems or treatments.I haven't had cancer treatment, including chemo or targeted therapy, in the last 4 weeks.I have urothelial carcinoma or cholangiocarcinoma and standard treatments haven’t worked or aren’t suitable for me.My tumor has specific FGFR2/3 genetic changes.I have brain metastases that are causing symptoms or need steroids.I have not received any live vaccines within the last 4 weeks.My side effects from cancer treatments are mild, except for hair loss and skin color changes.I have serious heart problems or uncontrolled high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: ABSK061
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently accepting new participants?
"Clinicaltrials.gov reports that recruitment for this medical study is still ongoing, having been posted on June 30th 2022 and last updated November 14th 2022."
Answered by AI
What is the enrollment capacity for this experiment?
"Yes, clinicaltrials.gov shows that this clinical trial is actively recruiting patients. It was initially posted on June 30th 2022 and the most recent edits were made November 14th 2022. The study requires 85 people to be enrolled from a single site."
Answered by AI
What are the primary goals of this investigation?
"This clinical trial aims to evaluate the rate and intensity of adverse reactions at Cycle 1's conclusion (28 days). Secondary objectives encompass Progression-free Survival, Maximun Observed Concentration, as well as Time To Maximum Observed Concentration."
Answered by AI
Is ABSK061 a safe drug to administer to patients?
"Due to the limited evidence available on ABSK061, our team at Power rated its safety profile with a 1. This is because this drug has only passed Phase 1 trials and not yet proven efficacy or established safety standards."
Answered by AI
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