KB707 for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called KB707 for individuals with advanced cancers. The goal is to determine the safety and efficacy of KB707, either alone or in combination with other medicines like Opdualag or Keytruda. It specifically targets individuals with solid tumors or advanced melanoma that have not responded to standard treatments. This trial may suit those with advanced melanoma who have tried other treatments but need new options. Participants will receive KB707 through injections directly into the tumor. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you must be fully recovered from prior surgery or radiation therapy and not require systemic corticosteroids. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that KB707, when used alone, has been safe and well-tolerated in past studies. Patients handled the treatment well, and no maximum safe dose was identified, suggesting it is generally safe.
More information is needed when KB707 is combined with Opdualag. However, the FDA has already approved Opdualag for treating advanced melanoma, confirming its safety for that use. The safety of combining it with KB707 remains under study.
Similarly, the combination of KB707 with Keytruda is under investigation. Keytruda is a well-known cancer treatment and is generally considered safe for its approved uses. However, the safety of using it with KB707 is still being researched.
In summary, KB707 alone has shown good safety results. While combining it with Opdualag and Keytruda appears promising, these combinations are still being closely monitored to ensure safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about KB707 because it offers a new approach to treating advanced cancers, particularly solid tumors and melanoma. Unlike traditional therapies, KB707 is being tested both as a standalone treatment and in combination with immune checkpoint inhibitors like Opdualag and Keytruda, which are standard treatments for melanoma. The combination with these powerful drugs may enhance the body's immune response against cancer cells, potentially leading to better outcomes. This novel strategy could provide new hope for patients with advanced forms of cancer, especially those who have not responded well to existing treatments.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
Research has shown that KB707, a new treatment that helps the immune system fight cancer, looks promising for advanced cancers. In earlier studies, 36% of patients who used inhaled KB707 experienced tumor shrinkage, meaning more than one in three patients had positive results. In this trial, some participants will receive KB707 monotherapy, while others will receive KB707 combined with Opdualag or Keytruda. When used with Opdualag, a current melanoma treatment, patients experienced longer periods without cancer progression. Additionally, Keytruda has demonstrated that more than a third of patients were still alive 10 years after treatment. While research is ongoing, these results suggest that KB707 could be effective, especially when combined with other treatments.13456
Who Is on the Research Team?
David Chien, MD
Principal Investigator
Senior Vice President of Clinical Development
Are You a Good Fit for This Trial?
Adults with advanced or metastatic solid tumors who have not benefited from standard treatments, can't handle them, refused them, or have no available options. Participants must be over 18, have a tumor that can be injected through the skin and expected to live more than 12 weeks. They should also be relatively active and able to care for themselves (ECOG status of 0 or 1). Pregnant individuals or those on recent cancer therapies are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Subjects receive intratumoral injections of KB707 approximately every three weeks in dose escalation cohorts
Dose Expansion
Subjects receive intratumoral injections of KB707 in combination with Opdualag or Keytruda, biweekly
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KB707
Find a Clinic Near You
Who Is Running the Clinical Trial?
Krystal Biotech, Inc.
Lead Sponsor