A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
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ClinicalTrials.gov Identifier: NCT06228326 |
Recruitment Status :
Recruiting
First Posted : January 29, 2024
Last Update Posted : April 24, 2024
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
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 |
- 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
- 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 |
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)
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
Contact: David Chien, MD | 412-586-5830 | dchien@krystalbio.com | |
Contact: Brittani Agostini, RN, CCRC | 412-586-5830 | bagostini@krystalbio.com |
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 |
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 |
solid tumors cancer Krystal Biotech |
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 |