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

Krystal Biotech

Status and phase: Enrolling; Phase 1

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

Treatments: Biological: KB707

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970497

KB707-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: KB707

Dose expansion of KB707 by IT injection

Experimental group

Description:

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

Treatment:

Biological: KB707