Clinical Trial

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

Recruiting Phase 1
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Summary
The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors. The main objectives of this study are : * To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101 * to show preliminary antitumor activity in patients with advanced solid tumors Participants will: * Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. * Undergo regular tumor imaging to assess response. * Provide blood samples for pharmacokinetics (PK) and biomarker analysis. * Be monitored for side effects and overall tolerability. This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-17; most recent amendment 2026-01-08.
Trial Details
NCT Number NCT07181473
Lead Sponsor Phrontline Biopharma
Conditions Lung Cancer (NSCLC), Prostate Cancer, Esophageal Cancer, Solid Tumor Malignancies
Enrollment 200 participants
Start Date 2025-08-25
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-01-12