First-in-human testing of 3H-10000 for unresectable or metastatic lung and stomach cancers
Official title: A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors
Run by 3H Pharmaceuticals Co., Ltd. · NCT07354711 · Data updated 2026-11-12
This trial will test whether the experimental drug 3H-10000 is safe and helps adults with unresectable or metastatic lung or stomach cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | 3H Pharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 4, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07354711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with unresectable or metastatic lung or stomach cancer who have at least one measurable lesion, ECOG 0-1, life expectancy ≥3 months, and can comply with study visits are ideal candidates.
✕Probably not a fit
Patients with meningeal disease, uncontrolled effusions requiring frequent drainage, unresolved significant adverse events from prior therapy, recent investigational drug exposure, or significant corneal/retinal disease are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human, Phase 1/2 interventional trial starts with a dose-escalation phase to define safety, tolerability, and the recommended dose, followed by dose-expansion cohorts to gather preliminary efficacy data. Investigators will collect pharmacokinetic and pharmacodynamic data and monitor adverse events closely to identify dose-limiting toxicities. Eligible adults must have measurable unresectable or metastatic disease by RECIST v1.1 and an ECOG performance status of 0-1. The study is conducted at Beijing Cancer Hospital and includes regular clinic visits for dosing and tumor assessments.
Why it matters
Potential benefit: If successful, 3H-10000 could provide a new treatment option that slows tumor growth or extends life for people with advanced lung or stomach cancers.
How similar studies have gone: This is a first-in-human trial of 3H-10000, so its specific approach is untested in people, though other targeted and experimental agents have shown benefit in similar tumor types.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be willing and able to sign the ICF and to adhere to the study visit schedule and other protocol requirements. * Male or female subjects aged ≥18 years at the time of signing the ICF. * According to RECIST v1.1, there is at least one measurable lesion. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point. * Life expectancy of ≥3 months. Exclusion Criteria: * Meningeal diseases or carcinomatous meningitis. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage every two weeks or more frequently. * Having received treatment with other investigational drugs within 4 weeks prior to the first dose of the study drug. * Any AEs induced by prior anti-tumor therapy having not resolved to Grade 1 or lower (except for alopecia or any other Grade 2 AEs assessed by the investigator as not being associated with any safety risk). * Any corneal or retinal disease/keratopathy assessed by the investigator as of clinical significance, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis.
Where it's running
-
Beijing Cancer Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Shuchao Wu
- Email: shuchao.wu@3hpharma.com
- Phone: 0086-21-50895559
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI language tools to help tumor care teams write MDT reports
We will test whether AI language tools can help junior cancer doctors write MDT diagnosis and treatment reports more accurately and faster.
-
18F-G1 PET/CT to see early immunotherapy response in solid tumors and blood cancers
We are testing if the 18F-G1 PET/CT scan can help tell early on whether people with solid tumors or blood cancers will respond to immunotherapy.
-
Using brodalumab to treat immune-related side effects from cancer therapy
This study is testing if brodalumab can help cancer patients who are having immune-related side effects from their immunotherapy treatment feel better.
-
Treatment of Taxane-resistant Cancers with Paclitaxel Polymeric Micelles
This study is testing a new form of chemotherapy called Paclitaxel Polymeric Micelles to see if it can help people with advanced cancers that didn't respond to standard Taxane treatments.
-
Validation of a blood test for early cancer detection and monitoring
This study is testing a blood test to see if it can help find different types of cancer early and monitor patients after treatment.
-
ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden
This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.