Phase I Study of TJ101 Antibody-Drug Conjugate to Assess Safety, Dosage, and Effectiveness in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying TJ101, an investigational antibody-drug conjugate ADC, in adults with advanced or metastatic solid tumors who have no remaining standard treatment options. This Phase I, first-in-human trial aims to determine the maximum tolerated dose and recommended dose for expansion of TJ101, while assessing its safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor effects. Participants will receive intravenous infusions of TJ101 every three weeks, either at escalating doses during dose escalation or at selected doses during dose expansion. The study includes two parts Phase Ia to find safe dosage levels using a 33 design with up to 72 patients, and Phase Ib to further evaluate safety and anti-tumor activity in 40-180 patients across tumor-specific groups. Treatment continues until disease progression, unacceptable toxicity, withdrawal, or investigator decision. During the trial, participants will undergo regular tumor imaging every 6 to 12 weeks to monitor response, provide blood samples for pharmacokinetic and biomarker analyses, and have ongoing safety monitoring including lab tests, vital signs, ECGs, eye exams, and skin checks. Follow-up includes a 30-day safety check after the last dose and survival follow-up every three months until death or study end. The study is expected to last about 2 to 3 years in total.

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors