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RECRUITING
NCT05970497
PHASE1/PHASE2

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

Sponsor: Krystal Biotech, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-10-31

Completion Date

2027-07

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

KB707

Genetically modified herpes simplex type 1 virus

DRUG

Opdualag

Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)

DRUG

KEYTRUDA ®( Pembrolizumab)

Immunotherapy (PD-1 immune checkpoint inhibitor)

Locations (15)

UCLA Health

Los Angeles, California, United States

Mission Dermatology Center

Rancho Santa Margarita, California, United States

BRCR Global

Weston, Florida, United States

IU Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Morristown Medical Center / Atlantic Health System

Morristown, New Jersey, United States

Weill Cornell Medicine-New York-Presbyterian Hospital

New York, New York, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Renovatio Clinical - El Paso

El Paso, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Renovatio Clinical - The Woodlands

The Woodlands, Texas, United States