Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04574583 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)
A Phase 1 study of Solid Tumors and Metastatic Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04574583 is a Phase 1 study of Solid Tumors and Metastatic Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04574583, a Phase 1 study of Solid Tumors and Metastatic Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors. Objective: To find a safe dose of SX-682 in combined treatment with Bintrafusp alfa and BN-CV301 vaccines and to see if this treatment will cause tumors to shrink. Eligibility: Adults age 18 and older with metastatic cancer may be eligible for the first part of the trial. Adults age 18 and older with metastatic triple negative breast cancer or p16 negative head and neck squamous cell cancer, and who are not candidates for curative surgery may be eligible for the second part of the trial. Design: Participants will be screened under a separate protocol. Participants may have tumor biopsies. They will have physical exams. Their symptoms and medicines will be reviewed. They will have blood tests. They will have electrocardiograms to evaluate their heart. Participants will have imaging scans of the chest, abdomen, and pelvis. They may have a procedure where a small tube with a tiny video camera is put into the nose to look at the throat if they have head and neck cancers. Participants will get bintrafusp alfa through an intravenous catheter. For this, a small tube is put into an arm vein. They will get BN-CV301 vaccines as injections in the arm or thigh. They will take SX-682 by mouth twice a day. They will take the study drugs up to 2 years. They will keep a medicine diary. Participants will have study visits every 2 weeks. They will have 1 or 2 follow-up visits within 30 days after they stop treatment. Then they will be monitored by phone or email for 2 years.
Conditions Studied
Interventions
- DRUG SX-682
- DRUG M7824
- BIOLOGICAL MVA-BN-CV301
- BIOLOGICAL recombinant fowlpox viral (FPV)-CV301
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2023-05-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04574583
The ClinicalTrials.gov registry entry for NCT04574583 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (96% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 4 interventions - of which SX-682 is the first listed.
NCT04574583 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04574583 about?
NCT04574583 is a clinical study titled "Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)". Background: Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors. Objective: To find a safe dose of SX-682 in combined treatment with Bi...
What is the current status of trial NCT04574583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-11-24. Estimated completion is 2023-05-19.
What conditions does trial NCT04574583 study?
This clinical trial studies the following conditions: Solid Tumors, Metastatic Cancer.
What interventions are being tested in trial NCT04574583?
The interventions under investigation include: SX-682 (DRUG), M7824 (DRUG), MVA-BN-CV301 (BIOLOGICAL), recombinant fowlpox viral (FPV)-CV301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04574583?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04574583 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
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.
-
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of INCB123667 in Subjects With Advanced Solid Tumors
RECRUITING · Phase 1
-
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
RECRUITING · Phase 1
-
Study of AUBE00 in Patients With Solid Tumors
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.