A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT05970497
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
240 participants
INTERVENTIONAL
2023-10-31
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohorts 1 through 4
Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors.
KB707
Genetically modified herpes simplex type 1 virus
Cohort 5
Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.
KB707
Genetically modified herpes simplex type 1 virus
Opdualag
Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
Cohort 6
Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.
KB707
Genetically modified herpes simplex type 1 virus
KEYTRUDA ®( Pembrolizumab)
Immunotherapy (PD-1 immune checkpoint inhibitor)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Krystal Biotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Chien, MD
Role: STUDY_DIRECTOR
Senior Vice President of Clinical Development
Locations
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UCLA Health
Los Angeles, California, United States
Mission Dermatology Center
Rancho Santa Margarita, California, United States
BRCR Global
Weston, Florida, United States
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Morristown Medical Center / Atlantic Health System
Morristown, New Jersey, United States
Weill Cornell Medicine-New York-Presbyterian Hospital
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical - The Woodlands
The Woodlands, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Anna C Pavlick, DO
Role: primary
Cancer Answer Line
Role: primary
Role: primary
Other Identifiers
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KB707-01
Identifier Type: -
Identifier Source: org_study_id
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