Lung Cancer, Non-small CellPhase 1/2KYANITE-1NCT06228326
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
A Phase 1/2 study testing KB707, Pembrolizumab (KEYTRUDA®) and Chemotherapy in people with Lung Cancer, Non-small Cell and Lung Cancer Metastatic, run by Krystal Biotech, Inc. at 14 sites in United States.
Trial summary
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell, Lung Cancer Metastatic, Solid Tumor, Adult
- What is being tested?
- KB707, Pembrolizumab (KEYTRUDA®) and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 14 sitesUnited States
- Study dates
- 17 Apr 2024to Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 lung lesion per RECIST v1.1 at Screening
- Cohorts 1 through 4 only: 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 has no standard of care therapy.
- Cohorts 5, 6, and 7 only: (1) Histologically or cytologically confirmed diagnosis of stage 3 or 4 NSCLC, as per American Joint Committee on Cancer (AJCC) staging system (8th edition) and (2) Subject must meet the following criteria of prior lines of therapy:
- Subject has previously received no more than one line of prior immune checkpoint inhibitor (ICI) with or without platinum-based chemotherapy, or no more than two prior lines of therapy when given the ICI and platinum-based chemotherapy sequentially as two separate lines.
- Subjects with an actionable mutation (e.g., EGFR, KRAS, ALK, or ROS1 genomic alteration), are permitted to have received one additional line of approved targeted therapy.
Who cannot join
- Not fully recovered from prior surgery or radiotherapy, including all radiation-related toxicities
- 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, 6, and 7 only:
- Subject has a known additional malignancy that is progressing or requires active treatment
- Subject has active brain metastases or leptomeningeal metastases
Show all 10Show fewer
- Prior anti-PD-1/PD-L1 therapy was intolerable and required discontinuation of treatment
- Subject has active, known, or suspected autoimmune disease requiring systemic treatment
- Subject has known acute or chronic hepatitis
- Subject has active pneumonitis or history of ICI-induced pneumonitis that required steroids
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 10 recruiting
- Recruiting
Precision NextGen Oncology
Beverly Hills, California, 90212
Brianna Heaviside, 424-777-0708, briannah@nextgenonc.com
Ravleen Kaur, 424-777-0708, RavKaur@NextGenOnc.com
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
Carrie Smith, RN, 330-492-3345, csmith@gabrailcancercenter.com
Kim Roby, 33-492-3345, kroby@gabrailcancercenter.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Cancer Answer Line, 216-444-7923
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Bethany Adams, RN, 313-556-8107, badams19@HFHS.ORG
Lisa Lange, RN, 313-556-8106, llange3@hfhs.org
- Recruiting
XCancer Research Network/Dothan Hematology & Oncology
Dothan, Alabama, 36303
Juli Love, 334-792-9500, juli@dothanhemonc.com
Tony Romero, 402-991-8468, tony@xcancer.com
- Terminated
Renovatio Clinical
El Paso, Texas, 79915
- Terminated
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
Sarah Cannon Research Institute
Nasville, Tennessee, 37203
Sarah Cannon Research Institute, (844) 482-4812, asksarah@sarahcannon.com
- Recruiting
Ochsner/MD Anderson Cancer Center
New Orleans, Louisiana, 70121
Jill Collins, BA, CCRA, 504-842-2466, jill.collins@ochsner.org
Amanda Woolery, RN, BSN, 504-842-0275
- Terminated
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Emad Ibrahim MD Inc
Redlands, California, 92373
Patricia Ramos, RN, 909-478-7973, pramos@redlandshospital.org
Katherine Wall, 909-478-7973, kwall@redlandshospital.org
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Oncology Clinical Trials Nurse Navigator, 480-323-1791, clinicaltrials@honorhealth.com
Oncology Clinical Trials Nurse Navigator, 833-354-6667
- Terminated
Renovatio Clinical
The Woodlands, Texas, 77380
- Recruiting
BRCR Global
Weston, Florida, 33326
Vaneska Chacin, 561-447-0614 ext. 109, vchacin@brcrglobal.com
Maria Abreu, 561-447-0614 ext. 106, mabreu@brcrglobal.com
About this study
Official title: KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies.
This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707.
Read more
Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase.
Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks.
All subjects will be treated 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.
- Conditions
- Lung Cancer, Non-small Cell, Lung Cancer Metastatic, Solid Tumor, Adult, Advanced Cancer, Lung Cancer (NSCLC)
- Being tested
- KB707, Pembrolizumab (KEYTRUDA®), Chemotherapy, Docetaxel
- Keywords
- cancer, Krystal Biotech, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB707Biological
Genetically modified herpes simplex type 1 virus
Pembrolizumab (KEYTRUDA®)Drug
PD-1 immune checkpoint inhibitor
ChemotherapyDrug
SOC chemotherapy
DocetaxelDrug
SOC chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 through 4 | Experimental | Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumor malignancies affecting the lungs. Receives: Biological: KB707 |
| Cohort 5 | Experimental | Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 60 subjects with NSCLC. Receives: Biological: KB707; Drug: Pembrolizumab (KEYTRUDA®) |
| Cohort 6 | Experimental | Dose expansion cohort: KB707 administered in combination with Keytruda and chemotherapy in approximately 60 subjects with NSCLC. Receives: Biological: KB707; Drug: Pembrolizumab (KEYTRUDA®); Drug: Chemotherapy |
| Experimental: Cohort 7 | Experimental | Dose expansion cohort: KB707 administered in combination with docetaxel in approximately 50 subjects with NSCLC. Receives: Biological: KB707; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)
Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5
Measured: up to 36 months
Secondary outcomes (2)
To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs)
Incidence of dose limiting toxicity (DLT) by dose cohorts
Measured: up to 36 months
To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)
Percentage of ORR for all participants
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start17 Apr 2024
- Primary completionFeb 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- More trials run by Krystal Biotech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krystal Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Chien, MD, Study director, Senior Vice President of Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228326
- Sponsor's protocol ID
- KB707-02
- Acronym
- KYANITE-1
- Status last verified
- Oct 2025
- First submitted
- 18 Jan 2024
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
- ClinicalTrials.gov ID
- NCT06228326
- Acronym / sponsor ID
- KYANITE-1 / KB707-02
- Conditions
- Lung Cancer, Non-small Cell, Lung Cancer Metastatic, Solid Tumor, Adult, Advanced Cancer, Lung Cancer (NSCLC)
- Keywords
- cancer, Krystal Biotech, lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Krystal Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies.
This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707.
Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase.
Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks.
All subjects will be treated 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 through 4 | Experimental | Biological: KB707Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumor malignancies affecting the lungs. |
| Cohort 5 | Experimental | Biological: KB707, Drug: Pembrolizumab (KEYTRUDA®)Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 60 subjects with NSCLC. |
| Cohort 6 | Experimental | Biological: KB707, Drug: Pembrolizumab (KEYTRUDA®), Drug: ChemotherapyDose expansion cohort: KB707 administered in combination with Keytruda and chemotherapy in approximately 60 subjects with NSCLC. |
| Experimental: Cohort 7 | Experimental | Biological: KB707, Drug: DocetaxelDose expansion cohort: KB707 administered in combination with docetaxel in approximately 50 subjects with NSCLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 lung lesion per RECIST v1.1 at Screening
- Cohorts 1 through 4 only: 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 has no standard of care therapy.
Key exclusion criteria (10 listed)
- Not fully recovered from prior surgery or radiotherapy, including all radiation-related toxicities
- 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, 6, and 7 only:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB707Genetically modified herpes simplex type 1 virus | Biological | Cohort 5, Cohort 6, Cohorts 1 through 4, Experimental: Cohort 7 |
| Pembrolizumab (KEYTRUDA®)PD-1 immune checkpoint inhibitor | Drug | Cohort 5, Cohort 6 |
| ChemotherapySOC chemotherapy | Drug | Cohort 6 |
| DocetaxelSOC chemotherapy | Drug | Experimental: Cohort 7 |
Primary outcome
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
2 secondary outcomes
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
To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Chien, MD study director
Senior Vice President of Clinical Development
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KB707, Pembrolizumab (KEYTRUDA®) and Chemotherapy in people with Lung Cancer, Non-small Cell and Lung Cancer Metastatic, run by Krystal Biotech, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Chien, MD (412-586-5830, dchien@krystalbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.