KB707 for Lung Cancer

Phase 1 & 2

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

Must not have

Have known history of positive human immunodeficiency virus (HIV 1/2)

Prior oncology therapy (chemotherapy, immunotherapy, biological therapy) or use of an investigational agent or an investigational device within 21 days or 5 half-lives before administration of first dose of KB707, whichever is shorter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known history of HIV.

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I haven't had cancer treatment or used experimental drugs/devices within the last 21 days or 5 half-lives.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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)