Back to resultsA Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Primary Purpose
Cancer, Melanoma Stage III, Melanoma Stage IV
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
KB707
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
Dose expansion of KB707 by IT injection
Arm Description
Dose escalation of single-agent KB707 in 3 cohorts by IT injection
Dose escalation of single-agent KB707 in superficial and deep/visceral solid tumors
Outcomes
Primary Outcome Measures
Percentage of adverse events (AEs)
Percentage of subjects with adverse events (AEs)
Percentage of serious adverse events (SAEs)
Percentage of subjects with serious adverse events (SAEs)
Secondary Outcome Measures
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
Percentage of overall response rate (ORR)
Percentage of ORR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05970497
Brief Title
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Official Title
A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krystal Biotech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma, Osteosarcoma, Carcinoma, Squamous Cell, Carcinoma, Basal Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
Arm Type
Experimental
Arm Description
Dose escalation of single-agent KB707 in 3 cohorts by IT injection
Arm Title
Dose expansion of KB707 by IT injection
Arm Type
Experimental
Arm Description
Dose escalation of single-agent KB707 in superficial and deep/visceral solid tumors
Intervention Type
Biological
Intervention Name(s)
KB707
Intervention Description
Genetically modified herpes simplex type 1 virus
Primary Outcome Measure Information:
Title
Percentage of adverse events (AEs)
Description
Percentage of subjects with adverse events (AEs)
Time Frame
up to 36 months
Title
Percentage of serious adverse events (SAEs)
Description
Percentage of subjects with serious adverse events (SAEs)
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
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
Time Frame
up to 36 months
Title
Percentage of overall response rate (ORR)
Description
Percentage of ORR
Time Frame
up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittani Agostini, RN, CCRC
Phone
412-586-5830
Email
bagostini@krystalbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Chien, MD
Organizational Affiliation
Senior Vice President of Clinical Development
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
We'll reach out to this number within 24 hrs