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

May 14, 2025 updated by: Krystal Biotech, Inc.

A Phase 1/2, 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 1/2, open-label, multicenter, dose escalation and expansion study. The study will 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 as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma.

Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 and Cohort 6 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w per prescribing information). All subjects will be treated until disease progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.

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 and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors, including advanced melanoma. 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 as well as combination therapy of KB707 with immune checkpoint inhibitor therapy.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2
  • 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
      • Los Angeles, California, United States, 90095
      • Rancho Santa Margarita, California, United States, 92688
    • Florida
      • Weston, Florida, United States, 33326
    • 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
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Cancer Institute
        • Contact:
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center / Atlantic Health System
        • Contact:
    • 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
      • Canton, Ohio, United States, 44718
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Cancer Answer Line
          • Phone Number: 216-444-7923
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
    • 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:

  • Life expectancy >12 weeks
  • ECOG performance status of 0 or 1
  • Have measurable disease per RECIST v1.1 at Screening
  • Cohorts 1-4 only: 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.

  • Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and

    1. Subject has previously failed one prior anti-PD-1/PD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4); and
    2. If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor
  • Cohort 5 only: Age 12 years or older at the time of informed consent
  • Cohort 6 only: Age 18 years or older at the time of informed consent

Key Exclusion Criteria:

  • Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
  • 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)

  • Cohorts 5 and 6 only:

    1. Subject has a known additional malignancy that is progressing or requires active treatment.
    2. Subject has uveal/ocular melanoma.
    3. The subject has active brain metastases or leptomeningeal metastases
    4. Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma
    5. Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment

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: Cohorts 1 through 4
Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors.
Biological: KB707
Genetically modified herpes simplex type 1 virus
Experimental: Cohort 5
Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.
Biological: KB707
Genetically modified herpes simplex type 1 virus
Drug: Opdualag
Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
Experimental: Cohort 6
Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.
Biological: KB707
Genetically modified herpes simplex type 1 virus
Drug: KEYTRUDA ®( Pembrolizumab)
Immunotherapy (PD-1 immune checkpoint inhibitor)

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, 2027

Study Completion (Estimated)

July 1, 2027

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 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

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

product manufactured in and exported from the U.S.

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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