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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma, Osteosarcoma, Carcinoma, Squamous Cell, Carcinoma, Basal Cell

Intervention / Treatment
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* Biological: KB707


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors<br>Dose escalation of single-agent KB707 in 3 cohorts to treat superficial solid tumors | Biological: KB707<br>* Genetically modified herpes simplex type 1 virus<br>|
| Experimental: Dose expansion of KB707 by IT injection<br>Single-agent KB707 in superficial and deep/visceral solid tumors | Biological: KB707<br>* Genetically modified herpes simplex type 1 virus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adverse events (AEs) | Percentage of subjects with adverse events (AEs) | up to 36 months | 
| Percentage of serious adverse events (SAEs) | Percentage of subjects with serious adverse events (SAEs) | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) | 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 | up to 36 months | 
| Percentage of overall response rate (ORR) | Percentage of ORR | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumors, Krystal Biotech, cancer