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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05970497
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Krystal Biotech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Chien, MD
Principal Investigator Affiliation	Senior Vice President of Clinical Development
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma, Osteosarcoma, Carcinoma, Squamous Cell, Carcinoma, Basal Cell

Additional Details

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.

Arms & Interventions

Arms

Experimental: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors

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

Experimental: Dose expansion of KB707 by IT injection

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

Interventions

Biological: - KB707

Genetically modified herpes simplex type 1 virus

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Cancer Center, Palo Alto, California

Status

Recruiting

Address

Stanford Cancer Center

Palo Alto, California, 94305

Site Contact

Sunil Reddy, MD

[email protected]

650-498-6000

Mission Dermatology Center, Rancho Santa Margarita, California

Status