Phase 12 Study of 3H-10000 Infusion for Adults with Unresectable or Metastatic Lung or Stomach Cancer

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 III 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.

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