Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
FGFR Inhibitor for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by 3D Medicines (Beijing) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status of 0 or 1.
Adequate cardiac function left ventricular ejection fraction (LVEF) > 50% for 2 dimensional cardiac ultrasound.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, 3D185, to see if it is safe and effective in treating people with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They need to be relatively healthy, with a life expectancy of at least 12 weeks, good organ function, and no major surgery in the last month. They must not have certain heart conditions, uncontrolled high blood pressure, active infections like hepatitis B or C, recent biliary tract procedures that are unresolved, gastrointestinal issues affecting drug absorption, symptomatic brain metastases unless stable and untreated for at least a month.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new cancer drug called 3D185. It's designed to inhibit specific proteins (FGFR1-3) involved in tumor growth. This early-phase study will see how patients handle different doses and look for any signs that it might shrink their tumors.See study design
What are the potential side effects?
While specific side effects aren't listed here as this is an early-stage trial assessing safety and tolerability generally potential side effects may include digestive issues due to oral administration interference; liver function changes; possible impact on cardiac health given the exclusion criteria related to heart disease; electrolyte imbalances could indicate kidney or bone marrow involvement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My heart pumps well, with an ejection fraction over 50%.
Select...
My liver is functioning within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Evaluation: frequency and severity of AEs
Tolerability Evaluation: frequency and severity of AEs
Secondary outcome measures
Efficacy evaluation: Complete Response
Efficacy evaluation: Disease Progression
Efficacy evaluation: Partial Response
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Open-Label, Dose-EscalationExperimental Treatment1 Intervention
The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively. This study adopts an i3+3 method for dose escalation.
All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily [QD], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first
Find a Location
Who is running the clinical trial?
3D Medicines (Beijing) Co., Ltd.Lead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
ni LuStudy Director3D Medicines (Beijing) Co., Ltd.
Ni LuStudy Director3D Medicines (Beijing) Co., Ltd.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had treatment for a blocked bile duct within the last 14 days or still need medication for it.I do not have stomach or bowel problems that affect how I absorb medication.I have had eye conditions affecting the retina.I am not pregnant, breastfeeding, and willing to use contraception if of reproductive age.I have a history of diseases that cause vision loss.I am not on antiarrhythmic drugs except for beta blockers or digoxin.My kidney function is within the required range and my urine protein is low.I have had a heart attack recently.My heart condition does not severely limit my daily activities.I haven't taken strong CYP3A4 or CYP2C8 inhibitors or CYP3A4 inducers in the last week.I have an active hepatitis B or C infection.I have previously been treated with FGFR1-3 inhibitors.I have had a retinal detachment before.I have had a stroke or a mini-stroke.I haven't had uncontrollable fluid buildup in my chest or abdomen in the last 2 weeks.I have a history of age-related macular degeneration.I have had a blockage in the veins of my retina.I have an eye condition.I had major surgery or my surgery wound hasn't healed in the last 4 weeks.I have had serious heart problems in the last 6 months.I do not have severe or unstable chest pain.I am fully active or can carry out light work.I haven't had cancer treatment, except for certain drugs, in the last 4 weeks.My side effects from cancer treatment are mild or gone, except for possible hair loss, nerve damage, or hearing issues.My brain or spinal cancer is stable, and I haven't needed steroids in the last 2 weeks.I haven't had serious infections needing treatment in the last 2 weeks.My high blood pressure is not controlled by medication.I am taking low-dose warfarin or specific antiplatelet medications.My heart pumps well, with an ejection fraction over 50%.I am 18 years old or older.My cancer is advanced, and standard treatments haven't worked or aren't suitable for me.My organs and bone marrow are functioning well, and I haven't had blood treatments in the last week.My liver is functioning within the required limits.I have signed the consent form required for this study.I have had laser treatment or injections in the eye for macular degeneration.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label, Dose-Escalation
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.
Has the FDA granted approval for the utilization of Highly selective FGFR1-3 inhibitor?
"Our team at Power assigns the Highly selective FGFR1-3 inhibitor a safety score of 1, owing to its Phase 1 status and the limited amount of evidence concerning both its efficacy and security."
Answered by AI
Could patients currently participate in this experiment?
"Affirmative. Clinicaltrials.gov documents that the trial, first published on September 1st 2019, is actively enrolling participants. 42 individuals are required from one medical facility to complete this study."
Answered by AI
What is the end goal of this research initiative?
"The primary assessment criterion of this trial, measured over a two-year period is the Tolerability Evaluation metric which quantifies side effects. Secondary objectives consist of Pharmacokinetic Evaluations such as Volume of Distribution and Efficacy Evaluations including Complete Response rate and Objective Response Rate. PK parameters will be calculated using WinNonlin or SAS software packages to determine drug metabolism in human bodies."
Answered by AI
What is the capacity of this clinical trial in terms of participant numbers?
"Affirmative, the information on clinicaltrials.gov indicates that this experiment is still recruiting patients. It was initially made available in September of 2019 and then revised in September 2022. 42 participants are needed at a single location for the trial to be successful."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger