First-in-human testing of 3H-10000 for unresectable or metastatic lung and stomach cancers

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

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
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 3H Pharmaceuticals Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07354711 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shuchao Wu

Conditions: Lung Cancer, Stomach Cancer