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NCT07181473 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study of Prostate Cancer and Esophageal Cancer, sponsored by Phrontline Biopharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 7
- Study locations
NCT07181473 is a Phase 1 study of Prostate Cancer and Esophageal Cancer that is actively recruiting participants, run by Phrontline Biopharma. The registered enrollment target is 200 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT07181473, a Phase 1 study of Prostate Cancer and Esophageal Cancer, is actively recruiting participants, sponsored by Phrontline Biopharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 7
- Study locations
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-08-25 |
| Est. Completion | 2027-09-15 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower). The listed sponsor is Phrontline Biopharma, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT07181473 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Florida, Tennessee, Texas.
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).
What interventions are being tested in trial NCT07181473?
The interventions under investigation include: TJ101 (DRUG).
Who is sponsoring clinical trial NCT07181473?
This trial is sponsored by Phrontline Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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