Treatment of advanced lung cancer using KB707

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• XCancer Research Network/Dothan Hematology & Oncology
  Dothan, Alabama, United States Recruiting
• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Precision NextGen Oncology
  Beverly Hills, California, United States Recruiting
• Emad Ibrahim MD Inc
  Redlands, California, United States Recruiting
• BRCR Global
  Weston, Florida, United States Recruiting
• Ochsner/MD Anderson Cancer Center
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Study coordinator: David Chien, MD
• Email: dchien@krystalbio.com
• Phone: 412-586-5830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.