Actively Recruiting
A Phase I/II Study of 3H-10000, an Anti-FGFR2b Antibody-Drug Conjugate, in Patients With Unresectable or Metastatic Advanced Solid Tumors
Led by 3H Pharmaceuticals Co., Ltd. · Updated on 2026-01-21
170
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying 3H-10000, an anti-FGFR2b antibody-drug conjugate, to assess its safety, tolerability, effectiveness, pharmacokinetics, and pharmacodynamics in adults with unresectable or metastatic solid tumors such as lung and stomach cancer. This Phase I/II trial aims to find the best dose and schedule for this treatment and observe how it affects tumor response. The trial has two parts: a dose escalation phase where increasing amounts of 3H-10000 are given to patients with advanced solid tumors to determine the maximum tolerated or administered dose, followed by an expansion phase that evaluates the recommended Phase 2 dose and schedule identified earlier. The drug is administered by infusion every two weeks in 28-day cycles. Participants will be monitored for adverse events and serious adverse events up to about two years. Researchers will also assess tumor response rates, disease control, duration of response, and progression-free survival. Pharmacokinetic studies will be conducted multiple times during the first three months and throughout the expansion phase. The total participation time can last up to two years with regular visits and tests to evaluate safety and treatment effects.
CONDITIONS
Brief Title
A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be willing and able to sign the informed consent form and follow the study schedule.
- Male or female subjects aged 18 years or older.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
You will not qualify if you...
- Meningeal diseases or carcinomatous meningitis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage every two weeks or more often.
- Treatment with other investigational drugs within 4 weeks before the first study dose.
- Any adverse events from prior anti-tumor therapy not resolved to Grade 1 or lower, except alopecia or Grade 2 events deemed safe by the investigator.
- Clinically significant corneal or retinal disease or keratopathy, including bullous/band keratopathy, corneal abrasion, inflammation, ulceration, or keratoconjunctivitis as assessed by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive 3H-10000 by infusion every 2 weeks in 28-day cycles as part of dose escalation or expansion stages.
Infusion visits every 2 weeks during treatment cycles
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
S
Shuchao Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here