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RECRUITING Phase 1

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

NCT07181473 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG TJ101

Study Locations (7)

Florida

  • Florida Cancer Specialists & Research Institute — Orlando

Tennessee

  • Sarah Cannon Research Institute (SCRI) — Nashville

Texas

  • Oncology Consultants — Houston

Henan

  • Henan Cancer Hospital — Zhengzhou

Hubei

  • Union Hospital of Tongji Medical College — Wuhan

Zhejiang

  • Sir Run Run Shaw Hospital — Hangzhou

Other

  • Shanghai East Hospital — Shanghai

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2025-08-25
Est. Completion 2027-09-15
Phase Phase 1

Sponsor

Phrontline Biopharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07181473

The ClinicalTrials.gov registry entry for NCT07181473 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phrontline Biopharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which TJ101 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07181473 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Florida, Tennessee, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07181473 about?

NCT07181473 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors". 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 exp...

What is the current status of trial NCT07181473?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2025-08-25. Estimated completion is 2027-09-15.

What conditions does trial NCT07181473 study?

This clinical trial studies the following conditions: Prostate Cancer, Esophageal Cancer, Solid Tumor Malignancies, Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07181473?

The interventions under investigation include: TJ101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07181473?

This trial is sponsored by Phrontline Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07181473 being conducted?

This trial has 7 study locations across Florida, Tennessee, Texas, Henan, Hubei. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial