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NCT06228326 · ClinicalTrials.gov registry record · Phase 1

A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

A Phase 1 study of Advanced Cancer and Solid Tumor, Adult, sponsored by Krystal Biotech.

Recruiting
Registry status
Phase 1
Development phase
250
Enrollment target
14
Study locations

NCT06228326 is a Phase 1 study of Advanced Cancer and Solid Tumor, Adult that is actively recruiting participants, run by Krystal Biotech. The registered enrollment target is 250 participants, roughly in line with the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target. The trial reports 14 study locations across 11 states.

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The verdict

NCT06228326, a Phase 1 study of Advanced Cancer and Solid Tumor, Adult, is actively recruiting participants, sponsored by Krystal Biotech.

RECRUITING
Registry status
Phase 1
Development phase
250 participants
Enrollment target
14
Study locations

Study Summary

The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies. This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707. Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase. Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks. All subjects will be treated until tumor progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.

Conditions Studied

Advanced Cancer Solid Tumor, Adult Lung Cancer, Non-Small Cell Lung Cancer Metastatic Lung Cancer (NSCLC)

Interventions

  • DRUG Docetaxel
  • DRUG Chemotherapy
  • BIOLOGICAL KB707
  • DRUG Pembrolizumab (KEYTRUDA®)

Study Locations (14)

California

  • Precision NextGen Oncology - Beverly Hills
  • Emad Ibrahim MD Inc - Redlands

Ohio

  • Gabrail Cancer Center Research - Canton
  • Cleveland Clinic - Cleveland

Texas

  • Renovatio Clinical - El Paso
  • Renovatio Clinical - The Woodlands

Alabama

  • XCancer Research Network/Dothan Hematology & Oncology - Dothan

Arizona

  • HonorHealth Research Institute - Scottsdale

Florida

  • BRCR Global - Weston

Indiana

  • IU Simon Comprehensive Cancer Center - Indianapolis

Louisiana

  • Ochsner/MD Anderson Cancer Center - New Orleans

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2024-04-17
Est. Completion 2028-07
Phase Phase 1

Sponsor

Krystal Biotech

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06228326

The ClinicalTrials.gov registry entry for NCT06228326 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target. The listed sponsor is Krystal Biotech, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT06228326 reports 14 study locations spanning 11 distinct geographic areas - top geographies include California, Ohio, Texas.

Frequently Asked Questions

What is clinical trial NCT06228326 about?

NCT06228326 is a clinical study titled "A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs". The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebuliz...

What is the current status of trial NCT06228326?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2024-04-17. Estimated completion is 2028-07.

What conditions does trial NCT06228326 study?

This clinical trial studies the following conditions: Advanced Cancer, Solid Tumor, Adult, Lung Cancer, Non-Small Cell, Lung Cancer Metastatic, Lung Cancer (NSCLC).

What interventions are being tested in trial NCT06228326?

The interventions under investigation include: Docetaxel (DRUG), Chemotherapy (DRUG), KB707 (BIOLOGICAL), Pembrolizumab (KEYTRUDA®) (DRUG).

Who is sponsoring clinical trial NCT06228326?

This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06228326 being conducted?

This trial has 14 study locations across Alabama, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.