NCT07181473

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Phrontline Biopharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of TJ101, a bispecific antibody-drug conjugate (ADC) targeting EGFR and B7-H3, in patients with advanced or metastatic solid tumors. Study Objectives Phase Ia (Dose Escalation) * Primary: Assess safety/tolerability; determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose(s) for expansion (RDEs). * Secondary: Characterize PK profile, assess preliminary anti-tumor activity, and evaluate immunogenicity. Phase Ib (Dose Expansion) * Primary: Further assess safety and preliminary anti-tumor activity of TJ101 at the selected RDEs. * Secondary: Further characterize PK profile and immunogenicity. Study Design * Part 1: Dose Escalation (Phase Ia) * Up to 72 patients with advanced/metastatic solid tumors. * Six planned dose cohorts: IV every 3 weeks (Q3W). * Accelerated titration for first cohort; 3+3 design for subsequent cohorts. * Backfill cohorts (6-12 patients each) may be added at promising dose levels to refine safety, PK, and efficacy data. * DLT evaluation window: 21 days after first infusion (Cycle 1). * Safety Monitoring Committee (SMC) reviews all data to guide escalation, backfill, and RDE selection. Part 2: Dose Expansion (Phase Ib) * 40-180 patients, across tumor-specific cohorts * Patients randomized to 2-3 RDEs of TJ101. * 20-30 subjects per tumor type/dose level. * Expansion will refine safety/PK and assess anti-tumor activity in biomarker-selected subgroups. * Dosing: IV infusion on Day 1 of each 21-day cycle; continued until progression, unacceptable toxicity, withdrawal, or investigator decision. Study Procedures \& Monitoring * Screening: within 28 days prior to first dose. * Safety Monitoring: continuous AE collection, labs, vitals, ECOG, ECGs, ophthalmologic exams, skin checks. * Efficacy Assessments: imaging at baseline, then every 6 weeks (first 24 weeks), every 9 weeks thereafter, and every 12 weeks from year 2 until progression or new therapy. * PK/Immunogenicity Sampling: intensive during Cycles 1 and 3; serial sampling in later cycles. * Follow-up: * 30-day safety follow-up after last dose. * Survival follow-up every 3 months until death or study termination. Enrollment \& Duration * Estimated enrollment: up to 252 patients. * Study duration: \~ 2-3 years.

Conditions

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

Interventions

Type	Name	Description
DRUG	TJ101	TJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor.

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-12-30
• Completion: 2027-09-15
• First posted: 2025-09-18
• Last updated: 2026-01-12

Locations

7 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study