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NCT05092373 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax
A Phase 1 study of Advanced Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT05092373: Recruiting Phase 1 study of Advanced Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT05092373 is a Phase 1 study of Advanced Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 43 participants, below the 85-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05092373, a Phase 1 study of Advanced Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.
Primary Outcome
To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD),in combination with cabozantinib (Cohort 1) or with nab-paclitaxel and atezolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types. 1st cycle with at least 6 evaluable patients treated at the dose.
Conditions Studied
Interventions
- BIOLOGICAL Atezolizumab
- DRUG Cabozantinib S-malate
- DRUG Nab-paclitaxel
- PROCEDURE Tumor Treating Fields Therapy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-04-29 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What NCT05092373 shows while recruiting
NCT05092373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 85-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (49% lower).
The record links to 10 conditions, with Advanced Hepatocellular Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Atezolizumab is the first listed.
NCT05092373 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05092373 about?
NCT05092373 is a clinical study titled "Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax". This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced)....
What is the current status of trial NCT05092373?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2022-04-29. Estimated completion is 2026-09-01.
What conditions does trial NCT05092373 study?
This clinical trial studies the following conditions: Advanced Hepatocellular Carcinoma, Advanced Renal Cell Carcinoma, Advanced Ovarian Carcinoma, Advanced Breast Carcinoma, Advanced Endometrial Carcinoma.
What interventions are being tested in trial NCT05092373?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), Cabozantinib S-malate (DRUG), Nab-paclitaxel (DRUG), Tumor Treating Fields Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT05092373?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05092373 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05092373's enrollment target sits among peer trials
43 10th of 16 higher than 7 of 16 other Advanced Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Hepatocellular Carcinoma 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.
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