A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of KB707 in Subjects with Locally Advanced or Metastatic Solid Tumor Malignancies
M
Mateusz Opyrchal, MD, PhD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
1
3 participants needed
1 Location
Brief description of study
What is the 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. 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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma, Osteosarcoma, Squamous Cell Carcinoma, Basal Cell Carcinoma
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
Exclusion 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
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)
Updated on
01 Aug 2024.
Study ID: CTO-KB707-01, 21456
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