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

May 7, 2024 updated by: Krystal Biotech, Inc.

A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies

KB707-01 is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy. In this study, patients will receive KB707 via direct intratumoral (IT) injection into solid tumors to assess the safety and tolerability as well preliminary efficacy of KB707 monotherapy treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an anti-tumor immune response through the production of cytokines. This is a first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation portion for single agent KB707 and an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford Cancer Center
        • Contact:
      • Rancho Santa Margarita, California, United States, 92688
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • IU Simon Comprehensive Cancer Center
        • Contact:
        • Contact:
          • Yvonne LaFary, RN
          • Phone Number: (317) 278-5613
          • Email: ylafary@iu.edu
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine-New York-Presbyterian Hospital
        • Contact:
          • Anna C Pavlick, DO
          • Phone Number: 646-962-6444
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Cancer Answer Line
          • Phone Number: 216-444-7923
    • Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • El Paso, Texas, United States, 79915
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
      • The Woodlands, Texas, United States, 77380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or there is no standard of care therapy.
  • Age 18 years or older at the time of informed consent
  • Life expectancy >12 weeks
  • ECOG performance status of 0 or 1
  • Have at least one measurable and injectable tumor that is accessible by transcutaneous administration

Key Exclusion Criteria:

  • 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
  • The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707
  • Have known history of positive human immunodeficiency virus (HIV 1/2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
Dose escalation of single-agent KB707 in 3 cohorts to treat superficial solid tumors
Biological: KB707
Genetically modified herpes simplex type 1 virus
Experimental: Dose expansion of KB707 by IT injection
Single-agent KB707 in superficial and deep/visceral solid tumors
Biological: KB707
Genetically modified herpes simplex type 1 virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of adverse events (AEs)
Time Frame: up to 36 months
Percentage of subjects with adverse events (AEs)
up to 36 months
Percentage of serious adverse events (SAEs)
Time Frame: up to 36 months
Percentage of subjects with serious adverse events (SAEs)
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: up to 36 months
Assess whether the tested doses include the maximum tolerated dose (MTD) of KB707 based on the safety and response data collected during the dose escalation portion of the study
up to 36 months
Percentage of overall response rate (ORR)
Time Frame: up to 36 months
Percentage of ORR
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krystal Biotech, Inc.

Investigators

  • Study Director: David Chien, MD, Senior Vice President of Clinical Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB707-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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