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

NCT05970497 · tracked via the Priya Life Science USA tracker

Sponsor

Krystal Biotech, Inc.

Phase

Phase 1/2

Started

2023-10-31

Last updated

2025-05-18

Condition(s) studied

CancerMelanoma Stage IIIMelanoma Stage IVCutaneous Melanoma

Investigational drug(s) / intervention(s)

KB707OpdualagKEYTRUDA ®( Pembrolizumab)

KB707: Genetically modified herpes simplex type 1 virus

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

KEYTRUDA ®( Pembrolizumab): Immunotherapy (PD-1 immune checkpoint inhibitor)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: * Life expectancy \>12 weeks * ECOG performance status of 0 or 1 * Have measurable disease per RECIST v1.1 at Screening * Cohorts 1-4 only: 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. * Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and 1. Subject has previously failed one prior anti-PD-1/PD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4); and 2. If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor * Cohort 5 only: Age 12 years or older at the time of informed consent * Cohort 6 only: Age 18 years or older at the time of informed consent Key Exclusion Criteria: * Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids * 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) * Cohorts 5 and 6 only: 1. Subject has a known additional malignancy that is progressing or requires active treatment. 2. Subject has uveal/ocular melanoma. 3. The subject has active brain metastases or leptomeningeal metastases 4. Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma 5. Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment

Primary outcome measure(s)

Percentage of adverse events (AEs) — up to 36 months
Percentage of subjects with adverse events (AEs)
Percentage of serious adverse events (SAEs) — up to 36 months
Percentage of subjects with serious adverse events (SAEs)

Trial sites (15)

Facility	City	Region	Status
UCLA Health	Los Angeles	California	Recruiting
Mission Dermatology Center	Rancho Santa Margarita	California	Recruiting
BRCR Global	Weston	Florida	Recruiting
IU Simon Comprehensive Cancer Center	Indianapolis	Indiana	Recruiting
Henry Ford Cancer Institute	Detroit	Michigan	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	Recruiting
Morristown Medical Center / Atlantic Health System	Morristown	New Jersey	Recruiting
Weill Cornell Medicine-New York-Presbyterian Hospital	New York	New York	Recruiting
Gabrail Cancer Center Research	Canton	Ohio	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	Recruiting
Renovatio Clinical - El Paso	El Paso	Texas	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
Renovatio Clinical - The Woodlands	The Woodlands	Texas	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05970497 on ClinicalTrials.gov ↗ ← All trials in the USA