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Treatment of advanced lung cancer using KB707

KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs

Phase1; Phase2 Interventional Krystal Biotech, Inc. · NCT06228326

This study is testing a new treatment called KB707 to see if it can help adults with advanced lung cancer by boosting their immune response, especially for those who haven't had success with standard therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorKrystal Biotech, Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations14 sites (Dothan, Alabama and 13 other locations)
Trial IDNCT06228326 on ClinicalTrials.gov

What this trial studies

This study evaluates KB707, a novel therapy designed to stimulate an anti-tumor immune response in adults with advanced solid tumors affecting the lungs. It involves a Phase 1/2, open-label, multicenter approach that assesses the safety and tolerability of KB707, both as a standalone treatment and in combination with Keytruda and chemotherapy. Participants must have progressed on or be unable to tolerate standard therapies. The study includes a dose escalation phase followed by an expansion phase to further evaluate efficacy and immunologic effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumor malignancies affecting the lungs who have either progressed on, cannot tolerate, or refused standard of care therapies.

Not a fit: Patients with early-stage lung cancer or those who have not yet received standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who have limited treatment alternatives.

How similar studies have performed: Other studies using immune-based therapies for lung cancer have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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:

  1. 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.
  2. 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.

Key Exclusion Criteria:

* 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:

  1. Subject has a known additional malignancy that is progressing or requires active treatment
  2. Subject has active brain metastases or leptomeningeal metastases
  3. Prior anti-PD-1/PD-L1 therapy was intolerable and required discontinuation of treatment
  4. Subject has active, known, or suspected autoimmune disease requiring systemic treatment
  5. Subject has known acute or chronic hepatitis
  6. Subject has active pneumonitis or history of ICI-induced pneumonitis that required steroids

Where this trial is running

Dothan, Alabama and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung Cancer, Non-small CellLung Cancer MetastaticSolid Tumor, AdultAdvanced CancerLung CancercancerKrystal Biotechlung cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.