Clinical trial for Cancer
Official title A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05970497
What this study is testing
What is KB707?
KB707 is an investigational medicine being studied as a potential treatment for certain types of cancer. KB707 is designed to use a genetically modified virus to target and affect tumor cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check if KB707 is safe and to see if it helps shrink tumors when used alone or with other cancer drugs.
- Who it's for
- Adults with locally advanced or metastatic solid tumors, or unresectable or metastatic melanoma, who have stopped or cannot use standard treatments.
- What's involved
- Participants will receive injections of KB707 directly into their tumors. Some will also get other cancer drugs like Opdualag or Keytruda.
- Time commitment
- Treatment continues until the cancer grows, side effects become too hard to handle, or the study ends.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Life expectancy \>12 weeks
- ECOG performance status of 0 or 1
- Have measurable disease per RECIST v1.1 at Screening
- Cohorts 1-4 only: Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and the individual has progressed on standard of...
- Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC)...
You likely can't join if
- Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic...
- 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)
- Subject has a known additional malignancy that is progressing or requires active treatment.
- Subject has uveal/ocular melanoma.
- The subject has active brain metastases or leptomeningeal metastases
See the full eligibility criteria
- Life expectancy \>12 weeks
- ECOG performance status of 0 or 1
- Have measurable disease per RECIST v1.1 at Screening
- Cohorts 1-4 only: Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused...
- Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and
- Subject has previously failed one prior anti-PD-1/PD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4); and
- If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor
- Cohort 5 only: Age 12 years or older at the time of informed consent
- Cohort 6 only: Age 18 years or older at the time of informed consent Key
- Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
- 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)
- Subject has a known additional malignancy that is progressing or requires active treatment.
- Subject has uveal/ocular melanoma.
- The subject has active brain metastases or leptomeningeal metastases
- Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma
- Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Rancho Santa Margarita, California, United States
- Weston, Florida, United States
- Indianapolis, Indiana, United States
- Detroit, Michigan, United States
- Omaha, Nebraska, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Canton, Ohio, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- The Woodlands, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Rancho Santa Margarita, California, United States; Weston, Florida, United States; Indianapolis, Indiana, United States; Detroit, Michigan, United States; Omaha, Nebraska, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.