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Virus Therapy

KB707 for Advanced Cancer

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

Presence of at least one measurable and injectable tumor accessible by transcutaneous administration

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 tests a new drug (KB707) to see if it's safe & effective for adults with cancer that has progressed or they can't tolerate current treatments. Patients get the drug directly injected into tumors.

Who is the study for?

Adults with advanced or metastatic solid tumors who have not benefited from standard treatments, can't handle them, refused them, or have no available options. Participants must be over 18, have a tumor that can be injected through the skin and expected to live more than 12 weeks. They should also be relatively active and able to care for themselves (ECOG status of 0 or 1). Pregnant individuals or those on recent cancer therapies are excluded.Check my eligibility

What is being tested?

The trial is testing KB707's safety and potential effectiveness when directly injected into tumors of patients with various types of advanced cancers like melanoma and carcinoma. It's an early-phase study where everyone gets the same experimental treatment without any comparison group.See study design

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on safety, specific side effects aren't listed but may include reactions at the injection site, general immune responses due to activation by KB707, fatigue, fever, chills or other symptoms related to inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that can be measured and reached with a needle through the skin.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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

Percentage of adverse events (AEs)

Percentage of serious adverse events (SAEs)

Secondary outcome measures

Maximum tolerated dose (MTD)

Percentage of overall response rate (ORR)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansion of KB707 by IT injectionExperimental Treatment1 Intervention

Single-agent KB707 in superficial and deep/visceral solid tumors

Group II: Dose escalation of KB707 by intratumoral (IT) injection in solid tumorsExperimental Treatment1 Intervention

Dose escalation of single-agent KB707 in 3 cohorts to treat superficial solid tumors

0 / 3Eligibility 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.

Does this research program currently have any openings for participants?

"As seen on clinicaltrials.gov, this trial is actively enrolling patients; it was first posted to the website on October 31st and modified two days later."

Answered by AI

What is the maximum capacity for participants in this research project?

"That is correct. According to the website clinicaltrials.gov, this trial has been accepting applications since October 31st 2023 and remains open today. The study requires 80 individuals to be recruited from 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

2023. "A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05970497.

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