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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970497
• Other study ID #: KB707-01
• Status: Recruiting
• Phase: Phase 1
• Start date: October 31, 2023
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Krystal Biotech, Inc.
• Contact: David Chien, MD
• Phone: 412-586-5830
• Email: dchien[@]krystalbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Cutaneous Melanoma
• Melanoma
• Melanoma Stage III
• Melanoma Stage IV
• Osteosarcoma

Intervention

Biological:
• KB707
Genetically modified herpes simplex type 1 virus

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Renovatio Clinical - El Paso	El Paso	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Mission Dermatology Center	Rancho Santa Margarita	California
United States	Renovatio Clinical - The Woodlands	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Krystal Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of adverse events (AEs)	Percentage of subjects with adverse events (AEs)	up to 36 months
Primary	Percentage of serious adverse events (SAEs)	Percentage of subjects with serious adverse events (SAEs)	up to 36 months
Secondary	Maximum tolerated dose (MTD)	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
Secondary	Percentage of overall response rate (ORR)	Percentage of ORR	up to 36 months