Study on KB707 for Treating Advanced Lung Cancer
Sponsor: Krystal Biotech, Inc.
ClinicalTrials ID:NCT06228326
This clinical trial is testing a new treatment called KB707, which is delivered directly to the lungs to help the immune system fight advanced lung cancer. The study will also look at how well KB707 works with another cancer drug, Keytruda, and possibly chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is exploring a new treatment, KB707, which is a modified virus designed to boost the immune system's response against lung cancer. KB707 is given through a nebulizer, a device that turns liquid medicine into a mist, allowing it to be inhaled directly into the lungs. This trial is in its early stages (Phase 1/2) and aims to find out if KB707 is safe and how well it works in adults with advanced lung cancer who have not responded to, cannot tolerate, or have refused standard treatments. The study will also test KB707 in combination with Keytruda, a drug that helps the immune system fight cancer, with or without chemotherapy. Participants will receive KB707 treatment regularly, and the study will continue until the cancer progresses, the participant chooses to stop, or the study is ended by the researchers.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage 3 or 4 non-small cell lung cancer (NSCLC).
- 18 years or older.
- Expected to live more than 12 weeks.
- In good general health, able to carry out normal activities with some effort.
- Have at least one lung tumor that can be measured.
- Currently receiving or eligible to receive Keytruda.
- For certain groups (Cohorts 5 and 6):
- Have received no more than one prior treatment with an immune therapy drug, with or without chemotherapy, or no more than two treatments if given separately.
- If the cancer has specific genetic changes, may have received one additional targeted therapy.
Exclusion Criteria
- Not fully recovered from previous surgery or radiation treatment.
- Pregnant, nursing, or planning to become pregnant during the study and for three months after the last dose of KB707.
- Have a known HIV infection.
- For certain groups (Cohorts 5 and 6):
- Have another cancer that is getting worse or needs treatment.
- Have active cancer spread to the brain or spinal fluid.
- Could not tolerate previous treatment with immune therapy drugs.
- Have an active autoimmune disease needing treatment.
- Have known hepatitis infection.
- Have active lung inflammation or a history of lung inflammation caused by immune therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth Research Institute | 85258 | Scottsdale | Arizona |
| IU Simon Comprehensive Cancer Center | 46202 | Indianapolis | Indiana |
| Ochsner/MD Anderson Cancer Center | 70121 | New Orleans | Louisiana |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| Sarah Cannon Research Institute | 37203 | Nasville | Tennessee |
| Renovatio Clinical | 79915 | El Paso | Texas |
| Renovatio Clinical | 77380 | The Woodlands | Texas |
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