Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Respiratory Aspiration

Carcinoma, Hepatocellular

Carcinoma, Renal Cell

Sarcoma

Osteosarcoma

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Adenocarcinoma

Neoplasms, Connective and Soft Tissue

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Carcinoma, Bronchogenic

Bronchial Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Small Cell Lung Cancer

Dose escalation of single-agent KB707 in 3 cohorts in a standard 3+3 design.

Dose expansion of single-agent KB707 in approximately 60 subjects with advanced solid tumor malignancies affecting the lungs, including approximately 40 subjects with non-small cell lung cancer.

Genetically modified herpes simplex type 1 virus

KB707

David Chien, MD

Brittani Agostini, RN, CCRC

Julie Urban, PhD

Maya Fleyhan

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.

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

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

Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5

Incidence of dose limiting toxicity (DLT) by dose cohorts

Krystal Biotech, Inc.

Melanoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Neuroendocrine Tumor

Neuroepithelioma

Dose escalation of single-agent KB707 in 3 cohorts to treat superficial solid tumors

Single-agent KB707 in superficial and deep/visceral solid tumors

Sunil Reddy, MD

Shireen Guide, MD, FAAD

Anne Younger, RN

Yvonne LaFary, RN

Anna C Pavlick, DO

Brian Turpin, DO

Cancer Answer Line

Li Li

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.

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.

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

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

Percentage of subjects with adverse events (AEs)

Percentage of subjects with serious adverse events (SAEs)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs	NCT06228326	Lung Cancer, No... Lung Cancer Met... Solid Tumor, Ad... Advanced Cancer Lung Cancer, Sm... Metastatic Colo... Metastatic Rena... Metastatic Hepa... Metastatic Sarc... Metastatic Oste...	KB707	18 Years -	Krystal Biotech, Inc.
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors	NCT05970497	Cancer Melanoma Stage ... Melanoma Stage ... Cutaneous Melan... Osteosarcoma Carcinoma, Squa... Carcinoma, Basa...	KB707	18 Years -	Krystal Biotech, Inc.

Spots Global Cancer Trial Database for krystal biotech