Trial record 1 of 2 for:
kb707
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06228326 |
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Recruitment Status :
Recruiting
First Posted : January 29, 2024
Last Update Posted : April 24, 2024
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Sponsor:
Krystal Biotech, Inc.
Information provided by (Responsible Party):
Krystal Biotech, Inc.
- Study Details
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Brief Summary:
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector that is designed to stimulate an anti-tumor immune response through the production of cytokines delivered to the airways of people with advanced solid tumor malignancies affecting the lungs via nebulization. This Phase 1, open-label, multicenter, dose escalation and expansion study is designed to evaluate the safety and tolerability of KB707 in adults with with advanced solid tumor malignancies affecting the lungs who have progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The study will include a dose escalation portion for single agent KB707 using a standard 3+3 design followed by an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase. Subjects in both the dose escalation and dose expansion cohorts will receive KB707 via nebulization weekly for three weeks, then every three weeks for up to two years until tumor 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer, Non-small Cell Lung Cancer Metastatic Solid Tumor, Adult Advanced Cancer Lung Cancer, Small Cell Metastatic Colorectal Cancer Metastatic Renal Cell Carcinoma Metastatic Hepatocellular Carcinoma Metastatic Sarcoma Metastatic Osteosarcoma | Biological: KB707 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | KB707-02: A Phase 1 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs |
| Actual Study Start Date : | April 17, 2024 |
| Estimated Primary Completion Date : | February 2027 |
| Estimated Study Completion Date : | February 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dose Escalation of KB707 Administered via Nebulization
Dose escalation of single-agent KB707 in 3 cohorts in a standard 3+3 design.
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Biological: KB707
Genetically modified herpes simplex type 1 virus |
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Experimental: Dose Expansion of KB707 Administered via Nebulization
Dose expansion of single-agent KB707 in approximately 60 subjects with advanced solid tumor malignancies affecting the lungs, including approximately 40 subjects with non-small cell lung cancer.
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Biological: KB707
Genetically modified herpes simplex type 1 virus |
Primary Outcome Measures :
- To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE) [ Time Frame: up to 36 months ]Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5
Secondary Outcome Measures :
- To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs) [ Time Frame: up to 36 months ]Incidence of dose limiting toxicity (DLT) by dose cohorts
- To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR) [ Time Frame: up to 36 months ]Percentage of ORR for all participants
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Histologically confirmed diagnosis of advanced solid tumor malignancy affecting the lungs 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least one measurable lesion per RECIST v1.1 at Screening
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06228326
Contacts
| Contact: David Chien, MD | 412-586-5830 | dchien@krystalbio.com | |
| Contact: Brittani Agostini, RN, CCRC | 412-586-5830 | bagostini@krystalbio.com |
Locations
| United States, Texas | |
| Renovatio Clinical | Recruiting |
| El Paso, Texas, United States, 79915 | |
| Contact: Maya Fleyhan 713-703-2398 maya.fleyhan@renovatioclinical.com | |
| Renovatio Clinical | Recruiting |
| The Woodlands, Texas, United States, 77380 | |
| Contact: Maya Fleyhan 713-703-2398 maya.fleyhan@renovatioclinical.com | |
Sponsors and Collaborators
Krystal Biotech, Inc.
Investigators
| Study Director: | David Chien, MD | Senior Vice President of Clinical Development |
| Responsible Party: | Krystal Biotech, Inc. |
| ClinicalTrials.gov Identifier: | NCT06228326 |
| Other Study ID Numbers: |
KB707-02 |
| First Posted: | January 29, 2024 Key Record Dates |
| Last Update Posted: | April 24, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Krystal Biotech, Inc.:
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solid tumors cancer Krystal Biotech |
Additional relevant MeSH terms:
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Carcinoma Lung Neoplasms Carcinoma, Renal Cell Osteosarcoma Carcinoma, Non-Small-Cell Lung Small Cell Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Adenocarcinoma |
Sarcoma Neoplasms, Connective and Soft Tissue Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Kidney Diseases Urologic Diseases Male Urogenital Diseases Neoplasms, Bone Tissue Neoplasms, Connective Tissue Carcinoma, Bronchogenic Bronchial Neoplasms |