Study on KB707 for Treating Advanced or Metastatic Solid Tumors
Sponsor: Krystal Biotech, Inc.
ClinicalTrials ID:NCT05970497
This clinical trial is testing a new treatment called KB707 for adults with advanced or metastatic solid tumors, including melanoma, who have not responded to standard treatments or have no other treatment options.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate the safety and effectiveness of KB707, a genetically modified virus designed to boost the immune system's response against tumors. Participants will receive injections of KB707 directly into their tumors, either alone or in combination with other cancer drugs like Opdualag or Keytruda. The trial will help determine the best dose and assess how well the treatment works in shrinking tumors.
Description
KB707 is a specially modified virus that helps the immune system fight cancer by producing substances called cytokines. This study is the first time KB707 is being tested in humans. It will involve two parts: first, to find a safe dose of KB707 when used alone, and second, to test its effectiveness both alone and in combination with other cancer treatments. Participants will receive injections of KB707 directly into their tumors every few weeks. The study will continue until the cancer progresses, the patient experiences severe side effects, or other specified conditions occur.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumor that has not responded to standard treatments, cannot tolerate them, or has no standard treatment available.
- Be 12 years or older.
- Have a life expectancy of more than 12 weeks.
- Be in good overall health, with a performance status score of 0 or 1.
- Have measurable tumors based on specific medical criteria.
- For certain groups, have advanced melanoma that has not responded to previous treatments, including specific genetic mutations and prior therapies.
Exclusion Criteria
- Must have fully recovered from any previous surgery or radiation therapy.
- Cannot be pregnant, nursing, or planning to become pregnant during the study and for three months after the last dose of KB707.
- Cannot have a known history of HIV.
- For certain groups, cannot have another progressing cancer, eye melanoma, active brain cancer spread, or have received more than two lines of treatment for advanced melanoma.
- Cannot have had severe reactions to previous cancer treatments that required stopping the therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA Health | 90095 | Los Angeles | California |
| Stanford Cancer Center | 94305 | Palo Alto | California |
| Mission Dermatology Center | 92688 | Rancho Santa Margarita | California |
| IU Simon Comprehensive Cancer Center | 46202 | Indianapolis | Indiana |
| Henry Ford Cancer Institute | 48202 | Detroit | Michigan |
| Morristown Medical Center / Atlantic Health System | 07960 | Morristown | New Jersey |
| Weill Cornell Medicine-New York-Presbyterian Hospital | 10065 | New York | New York |
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
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