A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

Metastatic Colorectal Cancer Clinical Trial

Official title:

KB707-02: A Phase 1 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228326
• Other study ID #: KB707-02
• Status: Recruiting
• Phase: Phase 1
• Start date: April 17, 2024
• Est. completion date: February 2027

Study information

• Verified date: April 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

The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector that is designed to stimulate an anti-tumor immune response through the production of cytokines delivered to the airways of people with advanced solid tumor malignancies affecting the lungs via nebulization. This Phase 1, open-label, multicenter, dose escalation and expansion study is designed to evaluate the safety and tolerability of KB707 in adults with with advanced solid tumor malignancies affecting the lungs who have progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The study will include a dose escalation portion for single agent KB707 using a standard 3+3 design followed by an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase. Subjects in both the dose escalation and dose expansion cohorts will receive KB707 via nebulization weekly for three weeks, then every three weeks for up to two years until tumor 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Histologically confirmed diagnosis of advanced solid tumor malignancy affecting the lungs 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have at least one measurable lesion per RECIST v1.1 at Screening

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

• Advanced Cancer
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Lung Cancer Metastatic
• Lung Cancer, Non-small Cell
• Lung Cancer, Small Cell
• Lung Neoplasms
• Metastatic Colorectal Cancer
• Metastatic Hepatocellular Carcinoma
• Metastatic Osteosarcoma
• Metastatic Renal Cell Carcinoma
• Metastatic Sarcoma
• Osteosarcoma
• Small Cell Lung Carcinoma
• Solid Tumor, Adult

Intervention

Biological:
• KB707
Genetically modified herpes simplex type 1 virus

Locations

Country	Name	City	State
United States	Renovatio Clinical	El Paso	Texas
United States	Renovatio Clinical	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	To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)	Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5	up to 36 months
Secondary	To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs)	Incidence of dose limiting toxicity (DLT) by dose cohorts	up to 36 months
Secondary	To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)	Percentage of ORR for all participants	up to 36 months