Clinical trial for Clear Cell Renal Cell Carcinoma
Official title A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT05536141
What this study is testing
What is casdatifan?
casdatifan is an investigational medicine, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as AB521.
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 is testing whether casdatifan is safe and well tolerated in people with advanced solid tumors and kidney cancer. It also looks at how safe it is when combined with other drugs.
- Who it's for
- You may be able to join if you have clear cell kidney cancer or another advanced solid tumor and are not eligible for other treatments.
- What's involved
- You will receive casdatifan by mouth, either alone or with other medicines. You will have regular check‑ins and blood tests to monitor safety.
- Time commitment
- The study lasts about 6 months, with visits every few weeks for monitoring and medication.
- Phase 1: an early, usually small safety study
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
- Must have at least one measurable lesion per RECIST guidance
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
- Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
- Histologically confirmed ccRCC
- Creatinine clearance ≥ 40 mL/min Key
You likely can't join if
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
- Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's...
- History of trauma or major surgery within 28 days prior to the first dose of investigational product
- For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Note: Other protocol...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Melbourne, Australia
- Sydney, Australia
- Seoul, South Korea
- Barcelona, Spain
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 Birmingham, Alabama, United States; San Diego, California, United States; Santa Monica, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States and 14 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.