RecruitingPhase 1Phase 2NCT07354711

A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors

A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors


Sponsor

3H Pharmaceuticals Co., Ltd.

Enrollment

170 participants

Start Date

Jan 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3H-10000 in the treatment of unresectable or metastatic solid tumors .


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new cancer drug called 3H-10000 in patients with solid tumors (cancers involving organs or tissues) that cannot be removed by surgery or have spread to other parts of the body. The goal is to determine a safe dose and understand how the drug behaves in the body. **You may be eligible if:** - You are 18 years or older - You have an unresectable or metastatic solid tumor - You have at least one measurable tumor on imaging scans - You have good general health (ECOG performance status 0–1) - Your life expectancy is at least 3 months - You are willing and able to follow the study schedule **You may NOT be eligible if:** - You have cancer that has spread to the membranes lining the brain or spinal cord (carcinomatous meningitis) - You have uncontrolled fluid buildup around your lungs, heart, or abdomen requiring frequent draining - You have received another experimental drug within the past 4 weeks - You have unresolved serious side effects from prior cancer treatment - You have a significant cornea or retina eye condition (eye problems involving the surface of the eye or the retina) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG3H-10000

3H-10000 will be administered by infusion Q2W in 28-day cycles.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07354711


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