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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
Must not have
Prior oncology therapy (chemotherapy, immunotherapy, biological therapy) or use of an investigational agent or device within 21 days or 5 half-lives before administration of first dose of KB707, whichever is shorter
Known history of positive human immunodeficiency virus (HIV 1/2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatment or been in a trial for at least 21 days or 5 half-lives of the treatment, whichever is shorter.
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I have tested positive for HIV.

Timeline

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
Percentage of adverse events (AEs)
Percentage of serious adverse events (SAEs)
Secondary study objectives
Maximum tolerated dose (MTD)
Percentage of overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Krystal Biotech, Inc.Lead Sponsor
13 Previous Clinical Trials
365 Total Patients Enrolled
1 Trials studying Osteosarcoma
80 Patients Enrolled for Osteosarcoma
David Chien, MDStudy DirectorSenior Vice President of Clinical Development
6 Previous Clinical Trials
163 Total Patients Enrolled
1 Trials studying Osteosarcoma
80 Patients Enrolled for Osteosarcoma
~47 spots leftby Jul 2026
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