RecruitingPhase 1NCT07181473

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

A Phase I, First in Human (FIH), Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Preliminary Efficacy and Immunogenicity of TJ101 for Injection in Patients With Advanced/Metastatic Solid Tumors

Sponsor

Phrontline Biopharma

Enrollment

200 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Prostate Cancer Lung Cancer (NSCLC)Solid Tumor Malignancies

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-stage study testing the safety, how the body processes, and early signs of effectiveness of a new experimental drug in people with advanced or metastatic solid tumors that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor that has not responded to standard treatment or has no standard treatment available - You have at least one measurable area of cancer on imaging - You are in good general health (ECOG 0-1) - You have a life expectancy of at least 12 weeks - Your liver, kidney, and blood counts are within acceptable levels **You may NOT be eligible if...** - You have serious liver, kidney, or heart problems - You have active brain metastases or leptomeningeal disease - You are pregnant or breastfeeding - You have had prior treatments too recently (within the required washout period) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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