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Monoclonal Antibodies
ABSK121-NX for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Abbisko Therapeutics Co, Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the study completion, an average of half year
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a new drug to treat advanced solid tumors. It will look at the best dose to use and how it affects tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that have specific genetic changes in FGFR genes. Participants must be over 18, have a life expectancy of at least 3 months, measurable cancer according to certain criteria, and good organ and bone marrow function. They can't join if they've had recent cancer treatments or surgeries, are unable to swallow pills, or have other active cancers.Check my eligibility
What is being tested?
ABSK121-NX is being tested in this study. It starts with dose escalation to find the safest dose that patients tolerate well and then expands to more patients at this dose. The drug is taken orally in repeated cycles every 28 days to check its safety and how it affects different types of tumors.See study design
What are the potential side effects?
While the side effects for ABSK121-NX aren't listed here specifically, common side effects from drugs targeting FGFR alterations may include dry mouth, increased thirst, low phosphate levels in blood (hypophosphatemia), nail changes, hair loss or skin reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the study completion, an average of half year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the 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
AR
AUC
AUCtau,ss
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ABSK121-NXExperimental Treatment1 Intervention
Dose escalation of oral ABSK121-NX 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. Patients will receive a single dose of ABSK121-NX on Day -7 followed by a 7-day washout, as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD).
The dose escalation will start at 3 mg QD followed by dose escalation of a total of 8 potential dose levels. Once RDE is determined, an RDE-confirmation group of up to 24 more patients may be enrolled at the selected dose levels to further evaluate safety and efficacy (up to 12 per dose level/regimen), if approved by the sponsor. In addition, a preliminary food-effect (FE) may be evaluated in at least 6 patients from the RDE- confirmation part.
After the RDE is confirmed in the dose Escalation part, the dose Expansion phase will be conducted.
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Who is running the clinical trial?
Abbisko Therapeutics Co, LtdLead Sponsor
18 Previous Clinical Trials
1,134 Total Patients Enrolled
Yuan LuStudy DirectorWuxi Abbisko Biomedical Technology Co., Ltd.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a major surgery during the study.My phosphate levels have been high despite treatment.I cannot swallow pills or have a condition affecting my stomach or intestines.I am 18 years old or older.My side effects from previous cancer treatments are mild or gone.I haven't had cancer treatment like chemo or targeted therapy recently.I have previously been treated with FGFR inhibitors.My cancer has spread to my brain.I have not received a live vaccine recently.I have fluid buildup that is not responding to treatment.My organs and bone marrow are working well, as shown by recent tests.I have AIDS or tested positive for HIV.I do not have heart problems or diseases.I have been treated with FGFR inhibitors for my solid tumor.I have an advanced solid tumor.I have not taken FGFR inhibitors before for my cancer.I have UC or iCCA and my condition worsened after FGFR inhibitor treatment.I have another cancer that is getting worse or needs treatment.My advanced cancer has not responded to, or I cannot tolerate, standard treatments.I am fully active or can carry out light work.I have not had major surgery in the last 4 weeks.I haven't taken strong CYP3A4 drugs recently.My cancer has FGFR genetic changes confirmed by tests.
Research Study Groups:
This trial has the following groups:- Group 1: ABSK121-NX
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.
What is the primary objective of this research endeavor?
"The primary measure of this trial, assessed across a 28 day period, is the incidence and severity of adverse events. Secondary outcomes include duration of response (DoR), progression-free survival (PFS) as well as accumulation ratio (AR)."
Answered by AI
Has this experiment spread to multiple sites in the US?
"At present, the trial is running in 7 different cities - FuZhou, Haerbin and Shenyang as well as 4 additional locales. To reduce travel demands, it's best to choose a centre nearby when signing up for this research endeavour."
Answered by AI
Has the administration sanctioned ABSK121-NX for public use?
"The safety of ABSK121-NX, which is still in its first round of clinical trials, has been preliminarily assessed as a 1. This represents that the medication's efficacy and security are both relatively untested."
Answered by AI
Are there any current openings for this clinical research?
"Yes, the details available on clinicaltrials.gov confirm that this medical trial is presently recruiting participants. It was initially posted in June of 2023 and has since been updated; it seeks to enroll 169 patients across 7 sites."
Answered by AI
How many participants will be surveyed in this research endeavor?
"Indeed. Records on clinicaltrials.gov corroborate that this experimental trial, which was initially posted on June 26th 2023, is actively searching for participants. 169 individuals are required from 7 distinct sites to complete the study."
Answered by AI
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