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NCT05101356 · ClinicalTrials.gov registry record · Phase 1
A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by Tianhong Li.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT05101356 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by Tianhong Li. The registered enrollment target is 77 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05101356, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by Tianhong Li.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase 1/2 trial tests the safety and effectiveness of a cancer vaccine called Labvax 3(22)-23 and GM-CSF alone or in combination with pembrolizumab in treating adenocarcinoma that has spread to other places in the body (advanced stage). Labvax 3(22)-23 is designed to target a specific antigen (labyrinthin), which is a protein found on the surface of adenocarcinoma tumor cells. Labyrinthin is a protein that is not expressed on normal cells in the skin, lungs, salivary glands, pancreas, nor other tissues. In adenocarcinoma, the tumor cells produce too much labyrinthin causing them to express this protein on the surface of the tumor cells. One way to control the growth of these tumor cells is to teach the immune system to generate an immune response against the labyrinthin protein by vaccination against labyrinthin. GM-CSF, or sargramostim, is a protein that acts as a white blood cell growth factor. It has also been shown to stimulate immune system. Thus, administration of GM-CSF may help to boost the immune system response when given together with the vaccine. This study may improve the general knowledge about Labvax 3(22)-23 and how the body may generate an immune response to kill adenocarcinoma tumor cells. In the second phase of the study, participants will also receive pembrolizumab, which may improve anti-cancer activity when given with Labvax 3(22)-23 and GM-CSF.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Sargramostim
- BIOLOGICAL Antineoplastic Vaccine
Study Locations (1)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2021-10-13 |
| Est. Completion | 2030-01-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05101356
The ClinicalTrials.gov registry entry for NCT05101356 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (56% lower). The listed sponsor is Tianhong Li, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05101356 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05101356 about?
NCT05101356 is a clinical study titled "A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma". This phase 1/2 trial tests the safety and effectiveness of a cancer vaccine called Labvax 3(22)-23 and GM-CSF alone or in combination with pembrolizumab in treating adenocarcinoma that has spread to other places in the body (advanced stage). Labvax 3(22)-23 is designed to target a specific antigen (...
What is the current status of trial NCT05101356?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2021-10-13. Estimated completion is 2030-01-01.
What conditions does trial NCT05101356 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Advanced Adenocarcinoma, Metastatic Adenocarcinoma.
What interventions are being tested in trial NCT05101356?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Sargramostim (BIOLOGICAL), Antineoplastic Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05101356?
This trial is sponsored by Tianhong Li, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101356 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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