Kidney Cancer Clinical Trial

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 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.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT06228326

Recruitment Status:

Recruiting

Sponsor:

Krystal Biotech, Inc.

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There are 3 Locations for this study

See Locations Near You

UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Julie Urban, PhD
Contact
412-623-7396
[email protected]
Renovatio Clinical
El Paso Texas, 79915, United States More Info
Maya Fleyhan
Contact
713-703-2398
[email protected]
Renovatio Clinical
The Woodlands Texas, 77380, United States More Info
Maya Fleyhan
Contact
713-703-2398
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT06228326

Recruitment Status:

Recruiting

Sponsor:


Krystal Biotech, Inc.

How clear is this clinincal trial information?

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