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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: Recruiting Phase 1 study of Prostate Cancer and Esophageal Cancer, sponsored by Phrontline Biopharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Measuring the number of patients with Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematological toxicities: Grade 4 neutrophil count decreased lasting \>7 days; Grade ≥3 febrile neutropenia; Grade ≥3 platelet count decreased with clinically significant hemorrhage; Grade 4 anaemia; Non-Hematological toxicities: Death; Hy's law cases; Grade ≥3 non-hematological toxicities.
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 |
What NCT07181473 shows while recruiting
NCT07181473 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07181473's enrollment target sits among peer trials
200 221st of 735 higher than 504 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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