Renal Cell Carcinoma study: Casdatifan vs Zimberelimab
Official title Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC
ClinicalTrials.gov ID: NCT07397611
What this study is testing
What is Casdatifan?
an investigational oral tablet being studied as a potential treatment for resectable clear cell renal cell carcinoma (ccRCC) is designed to inhibit HIF-2α
Also referred to as C21H17F4NO3S, 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 checks if the drug casdatifan, alone or with zimberelimab, is safe and works well for people with a specific type of kidney cancer.
- Who it's for
- People with clear cell kidney cancer that can be removed by surgery.
- What's involved
- Participants will take casdatifan and possibly zimberelimab before their surgery.
- Time commitment
- The source text does not specify the total duration or visit schedule.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Adult patients age ≥ 18 years.
- Histologically confirmed diagnosis of ccRCC by a core-needle biopsy.
- Stage cT2 RCC with grade 4 or sarcomatoid features, ≥cT3 Nx RCC, or cTany N+ RCC disease for which partial or radical nephrectomy is planned.
- Participants must have measurable disease i.e. a primary renal tumor that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with...
- Participants must be planned for surgical resection of their primary renal tumor.
You likely can't join if
- Any prior systemic therapy for treatment of renal cell carcinoma.
- Any radiation therapy within 4 weeks before the first dose of study treatment.
- Any clear evidence of distant metastases. Enlarged lymph nodes that are planned to be removed during nephrectomy are permitted.
- Clinical pneumonitis or concern for inflammatory lung disease at time of screening.
- Any complementary medications (eg, herbal supplements or traditional Chinese medicines) with the intention to treat the disease under study within 2...
- Other prior malignancy active within the previous year except for locally curable cancers (\>90%) that have been apparently cured, such as basal or...
See the full eligibility criteria
- Adult patients age ≥ 18 years.
- Histologically confirmed diagnosis of ccRCC by a core-needle biopsy. Patients who have not had prior biopsy may undergo screening if they have suspected RCC but can only proceed to registration if ccRCC (any component)...
- Stage cT2 RCC with grade 4 or sarcomatoid features, ≥cT3 Nx RCC, or cTany N+ RCC disease for which partial or radical nephrectomy is planned. For clinical staging, a kidney MRI is highly preferred over a CT Abdomen.
- Participants must have measurable disease i.e. a primary renal tumor that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan or MRI.
- Participants must be planned for surgical resection of their primary renal tumor.
- ECOG performance status of 0-1.
- Absolute neutrophil count ≥ 1.0 × 10\^9/L without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.
- Platelet count ≥ 100 × 10\^9/L without transfusion within 2 weeks of screening laboratory sample collection.
- Hemoglobin ≥ 10.0 g/dL (or 6.2 mmol/L).
- Aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Bilirubin ≤ 1.5 × ULN (except participants with Gilbert syndrome who must have total bilirubin \< 3.0 mg/dL).
- Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- Ambulatory oxygen saturation \>92% on room air at time of screening.
- Serum albumin ≥ 2.8 g/dl.
- INR ≤ 1.5.
- Calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft-Gault equation: ---Males: (140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72) ---Females: [(140 - age) x weight (kg)/(serum...
- No exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.
- No active clinical pneumonitis at screening.
- No medical history of severe chronic obstructive pulmonary disease (COPD)
- Screening echocardiogram or MUGA scan must demonstrate a left ventricular ejection fraction (LVEF) greater than the institutional lower limit of normal (LLN).
- Negative serum pregnancy test at screening for women of childbearing potential. Female people are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization...
- Sexually active fertile people and their partners must agree to use highly effective methods of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is...
- Through 7 days after the last dose of casdatifan and 120 days after the last dose of zimberelimab for women of childbearing potential and for men
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow tablets.
- Any prior systemic therapy for treatment of renal cell carcinoma.
- Any radiation therapy within 4 weeks before the first dose of study treatment.
- Any clear evidence of distant metastases. Enlarged lymph nodes that are planned to be removed during nephrectomy are permitted.
- Clinical pneumonitis or concern for inflammatory lung disease at time of screening.
- Any complementary medications (eg, herbal supplements or traditional Chinese medicines) with the intention to treat the disease under study within 2 weeks before first dose of study treatment.
- Other prior malignancy active within the previous year except for locally curable cancers (\>90%) that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in...
- QTc ≥ 480 msec using Fridericia's correction (QTcF) (based on an average of triplicate recordings).
- Malabsorption condition that would alter the absorption of orally administered medications.
- Patient has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event...
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Cardiovascular disorders: i.
- Other clinically significant disorders that would preclude safe study participation.
- Active infection requiring systemic treatment. Note: Prophylactic antibiotic treatment is allowed.
- Infection with acute or chronic hepatitis B or C with detectable viral load, human immunodeficiency virus (HIV) infection with detectable viral load or acquired immunodeficiency syndrome (AIDS)-related illness.
- Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.
- Pharmacologically uncompensated, symptomatic hypothyroidism.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- History of solid organ or allogeneic stem cell transplant.
- Major surgery (as defined in Appendix B) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 7 days before the first dose of study treatment.
- Patients who are receiving treatment with strong CYP3A4 inhibitors and inducers should have a washout period of 28 days or 5 half-lives of the concerning medicine prior to starting casdatifan.
- History of psychiatric illness, mental condition or substance use disorders that are likely to interfere with ability to comply with protocol requirements or give informed consent.
- Use of any live vaccines against infectious diseases within 28 days of first dose of study drug.
- Current breastfeeding.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Any use of supplemental or intermittent oxygen therapy.
- Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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 Boston, Massachusetts, United States. 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.