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

Summary

The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies.

This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707.

Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase.

Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks.

All subjects will be treated 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.

Conditions

• Lung Cancer, Non-small Cell
• Lung Cancer Metastatic
• Solid Tumor, Adult
• Advanced Cancer
• Lung Cancer (NSCLC)

Interventions

BIOLOGICAL

KB707

Genetically modified herpes simplex type 1 virus

DRUG

Pembrolizumab (KEYTRUDA®)

PD-1 immune checkpoint inhibitor

DRUG

Chemotherapy

SOC chemotherapy

DRUG

Docetaxel

SOC chemotherapy

Sponsors & Collaborators

• Krystal Biotech, Inc.

  lead INDUSTRY

Principal Investigators

• David Chien, MD · Senior Vice President of Clinical Development

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-17

Primary Completion

2027-02-28

Completion

2028-07-31

FDA Drug

Yes

Countries

• United States

Study Locations