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Compares treatment options for Clear Cell Renal Cell Carcinoma
Official title An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT07469683
What this study is testing
What is SLC-3010 + Axitinib?
SLC-3010 + Axitinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
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 a phase 2, randomized study to evaluate the efficacy and safety of SLC-3010 in combination with axitinib versus axitinib monotherapy as second-line treatment in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC). This study includes a screening period, a treatment period, and a follow-up period.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- 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 19 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ccRCC.
- Part 1 (Safety Run-in): At least one first-line treatment of standard of care in the recurrent/metastatic setting.
- Part 2 (Phase 2): Anti-PD-1 (Programmed Cell Death Protein 1) or anti-PD-L1 (Programmed Cell Death-Ligand 1) monotherapy or combination therapy as...
- At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
- Male or female patients aged ≥ 19 years at the date on which the informed consent is signed.
You likely can't join if
- History of malignancy or active malignancy other than the target disease in this study. Exceptions are as follows:
- Malignancies that have been treated with curative intent and have not recurred within the recent 2 years.
- Completely resected basal cell carcinoma or squamous cell carcinoma of the skin.
- Any type of completely resected carcinoma in situ.
- Known brain metastases or epidural conditions. However, patients who have been sufficiently treated with radiotherapy and/or surgery (including...
- Diagnosis of immunodeficiency or current use of chronic systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first...
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ccRCC.
- Part 1 (Safety Run-in): At least one first-line treatment of standard of care in the recurrent/metastatic setting.
- Part 2 (Phase 2): Anti-PD-1 (Programmed Cell Death Protein 1) or anti-PD-L1 (Programmed Cell Death-Ligand 1) monotherapy or combination therapy as first-line treatment in the recurrent/metastatic setting.
- At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
- Male or female patients aged ≥ 19 years at the date on which the informed consent is signed.
- Ability and willingness to provide written informed consent and to comply with all study procedures.
- Estimated life expectancy of ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate organ functions as defined below. System organ class Laboratory test results \- Hematology : Absolute neutrophil count (ANC) ≥ 1500 cells/μL without the support of granulocyte colony-stimulating factor (G-CSF)...
- Coagulation :International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × the upper limit of normal (ULN). If the patient is receiving anticoagulant therapy, PT shall be within the therapeutic range for the...
- Kidney :Estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. ≥ 40 mL/min/1.73 m2
- Liver :Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome), or if total bilirubin is \> 1.5 × ULN, direct bilirubin ≤ ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤...
- If there were any clinically significant toxicities from prior therapies, they shall have resolved to Grade 0 or Grade 1 according to the NCI CTCAE v5.0 (Alopecia and ≤ Grade 2 endocrine-related adverse events related...
- Male and female patients of childbearing potential shall agree to use existing, highly effective contraception methods with the failure rate of \<1% (Appendix 1) during the treatment period and for 3 months after the...
- WOCBP shall have a documented negative serum or urine pregnancy test at screening, performed within 3 days prior to the first administration of the study intervention. For non-childbearing females, one of the following...
- Postmenopausal status, defined as the absence of regular menstruation for at least 12 consecutive months with a documented serum follicle-stimulating hormone (FSH) level within the laboratory reference range for...
- Documented history of hysterectomy or bilateral oophorectomy, or
- Medically confirmed ovarian failure.
What rules you out
- History of malignancy or active malignancy other than the target disease in this study. Exceptions are as follows:
- Malignancies that have been treated with curative intent and have not recurred within the recent 2 years.
- Completely resected basal cell carcinoma or squamous cell carcinoma of the skin.
- Any type of completely resected carcinoma in situ.
- Known brain metastases or epidural conditions. However, patients who have been sufficiently treated with radiotherapy and/or surgery (including radiosurgery) and have been stable for at least 4 weeks prior to the first...
- Diagnosis of immunodeficiency or current use of chronic systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first administration of the study intervention. Topical (\< Grade III)...
- Active autoimmune disease that has required systemic treatment (e.g., disease controllers, corticosteroids, or immunosuppressive drugs) within the recent 2 years. Replacement therapy (e.g., thyroxine, insulin, or...
- Known infection with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2. Known active hepatitis B virus infection (i.e., HBsAg positive) or hepatitis C virus infection (e.g., [qualitatively] detectable HCV RNA). Patients...
- Active infection requiring systemic therapy.
- Significant cardiovascular diseases, including but not limited to: Stable arrhythmias medically controlled with ongoing medication are allowed.
- QT interval (Interval from the start of the Q wave to the end of the T wave of the ECG) corrected for heart rate using Fridericia's formula (QTcF) \> 480 msec at screening
- Myocardial infarction, acute coronary syndrome, or history of coronary angioplasty/stenting/bypass grafting within the recent 6 months.
- Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II-IV, or a history of NYHA Class III or IV CHF.
- Patients with significant respiratory symptoms, known or suspected serious or severe pulmonary conditions at screening, or requiring supplemental oxygen.
- Any form of systemic anticancer therapy (including investigational therapy) within 3 weeks prior to the first administration of the study intervention, or within 5 half-lives of the drug if known, whichever is shorter.
- Participation in an treatment clinical trial involving an investigational drug or device within 3 weeks prior to the first administration of the study intervention in this clinical trial. Patients who are participating...
- Radiotherapy within 2 weeks prior to the first administration of the study intervention. Patients with ongoing clinically related complications from prior radiotherapy are not eligible.
- Major surgery within 2 weeks prior to administration of the study intervention. Patients shall have sufficiently recovered from any toxicity and/or complications at the discretion of the investigator.
- Live vaccine administration within 4 weeks prior to the first administration of the study intervention. Administration of non-live COVID-19 vaccines within 7 days prior to the DLT assessment is contraindicated, as...
- Prior therapy using IL-2 (interleukin-2)-based drugs.
- History of prior axitinib treatment.
- Inability to swallow oral drugs or presence of gastrointestinal disorders that may affect absorption (e.g., gastrectomy, partial bowel obstruction, or malabsorption syndrome).
- Current administration of potent CYP3A4 inducers (e.g., mitotane, phenytoin, rifampin, carbamazepine, or St. John's Wort) that cannot be discontinued during the study.
- Current administration of potent CYP3A4 inhibitors (e.g., boceprevir, cobicistat, itraconazole, ketoconazole, clarithromycin, idelalisib, nefazodone, nelfinavir, and ritonavir co-administered with protease inhibitors)...
- Medically significant bleeding within 3 months prior to randomization. Tumor invasion/infiltration of major blood vessels shall be evaluated, and the potential risk of severe hemorrhage due to tumor shrinkage or...
- Ongoing concomitant treatment at a therapeutic dose with anticoagulants such as heparin, thrombin, or factor Xa inhibitors, or with antiplatelet agents (e.g., clopidogrel).
- Low-dose aspirin (≤ 100 mg/day), prophylactic low molecular weight heparin (LMWH), and prophylactic factor Xa inhibitors are acceptable.
- Anticoagulation therapy with LMWH at a therapeutic dose is allowed in participants who have no radiologic evidence of uncontrolled brain metastases, have been on a stable dose of LMWH for at least 2 weeks prior to...
- Presence of the following clinically significant diseases:
- Unhealed serious active wounds, ulcers, or fractures
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ transplantation.
- Ascites with symptoms requiring medical intervention.
- Known hypersensitivity to any component of the study intervention (SLC-3010 or axitinib), or their analogs.
- Any condition, therapy, laboratory abnormality, or other circumstance (medical history or current evidence) that may expose the patient to risk by participating in the clinical trial, cause confusion in study results...
- Psychiatric or substance abuse disorders known to interfere with compliance with study requirements.
- For female patients only: Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.