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Virus Therapy

Dose Escalation of KB707 Administered via Nebulization for Sarcoma

Phase 1

Recruiting

Research Sponsored by Krystal Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older at the time of informed consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial is testing a new treatment called KB707 for people with advanced solid tumor malignancies affecting the lungs. KB707 is a virus that is designed to stimulate the body's immune response against the tumor

Who is the study for?

This trial is for adults with advanced lung-related cancers who have either not responded to, cannot handle, or chose not to undergo standard treatments. It's open to those with a variety of solid tumors in the lungs, including different types of lung cancer and other malignancies like osteosarcoma and liver cancer.Check my eligibility

What is being tested?

KB707 is being tested; it's a new type of therapy using a modified virus designed to boost the body’s immune response against lung tumors. Participants will inhale this treatment through nebulization. The study has two parts: first finding the right dose and then giving that dose to more people to see how well it works.See study design

What are the potential side effects?

While specific side effects for KB707 are not listed, similar treatments can cause flu-like symptoms, breathing issues, fatigue, and reactions at the administration site. As this is an early-phase trial assessing safety, close monitoring for any adverse effects will be part of the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)

Secondary outcome measures

To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)

To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion of KB707 Administered via NebulizationExperimental Treatment1 Intervention

Dose expansion of single-agent KB707 in approximately 60 subjects with advanced solid tumor malignancies affecting the lungs, including approximately 40 subjects with non-small cell lung cancer.

Group II: Dose Escalation of KB707 Administered via NebulizationExperimental Treatment1 Intervention

Dose escalation of single-agent KB707 in 3 cohorts in a standard 3+3 design.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Krystal Biotech, Inc.Lead Sponsor

12 Previous Clinical Trials

350 Total Patients Enrolled

David Chien, MDStudy DirectorSenior Vice President of Clinical Development

6 Previous Clinical Trials

163 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study actively seeking participants at the moment?

"Indeed, the information available on clinicaltrials.gov indicates that this clinical trial is actively seeking participants. The trial was initially posted on February 1st, 2024 and was last updated on January 18th, 2024. A total of 80 individuals will be enrolled in this study across two designated locations."

Answered by AI

Has the Food and Drug Administration granted approval for nebulized administration of KB707 with a gradual increase in dosage?

"Based on the trial being in Phase 1, indicating limited data supporting safety and efficacy, our team at Power rates the safety of Dose Escalation of KB707 Administered via Nebulization as a 1."

Answered by AI

What is the current number of individuals involved in this clinical trial as participants?

"Indeed, as per the details on clinicaltrials.gov, this study is actively seeking individuals to participate. The trial was posted for the first time on February 1st, 2024 and underwent its latest revision on January 18th, 2024. In total, there is a requirement of recruiting 80 patients from two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06228326.

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