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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.

Must not have

Subjects who received clinical intervention for biliary obstruction 14 days prior to the first dose or the Investigator judges that the symptoms had not resolved or required anti-infective treatment.

History of chorioretinal lesions;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am fully active or can carry out light work.

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My heart pumps well, with an ejection fraction over 50%.

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My liver is functioning within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had treatment for a blocked bile duct within the last 14 days or still need medication for it.

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I have had eye conditions affecting the retina.

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I am not pregnant, breastfeeding, and willing to use contraception if of reproductive age.

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I have a history of diseases that cause vision loss.

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I am not on antiarrhythmic drugs except for beta blockers or digoxin.

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I have had a heart attack recently.

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My heart condition does not severely limit my daily activities.

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I have an active hepatitis B or C infection.

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I have previously been treated with FGFR1-3 inhibitors.

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I have had a retinal detachment before.

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I have had a stroke or a mini-stroke.

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I have a history of age-related macular degeneration.

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I have had a blockage in the veins of my retina.

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I do not have severe or unstable chest pain.

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I haven't had serious infections needing treatment in the last 2 weeks.

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My high blood pressure is not controlled by medication.

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I am taking low-dose warfarin or specific antiplatelet medications.

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I have had laser treatment or injections in the eye for macular degeneration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety Evaluation: frequency and severity of AEs

Tolerability Evaluation: frequency and severity of AEs

Secondary study objectives

Efficacy evaluation: Complete Response

Efficacy evaluation: Disease Progression

Efficacy evaluation: Partial Response

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 21Eligibility criteria met