None listed
Conditions
Interventions
Drug : "Part 1 (Safety Run-in):
The safety run-in phase consists of a single-arm cohort of SLC-3010 in combination with axitinib and will be conducted to determine the optimal dose of the SLC-3010 co
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "1.Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ccRCC. a.Part 1 (Safety Run-in): At least one first-line treatment of standard of care in the recurrent/metastatic setting. b.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. 2.At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. 3.Male or female patients aged = 19 years at the date on which the informed consent is signed. 4.Ability and willingness to provide written informed consent and to comply with all study procedures. 5.Estimated life expectancy of = 3 months. 6.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 7.Adequate organ functions as defined below [Hematology] -Absolute neutrophil count (ANC) : = 1500 cells/µL without the support of granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to the first dose of the study intervention. -Platelet count : = 100,000/µL without the support of transfusion within 2 weeks prior to screening laboratory sample collection. -Hemoglobin : = 9 g/dL without the support of transfusion within 2 weeks prior to screening laboratory sample collection. [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 intended use of anticoagulants. [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) : = 2.5 × ULN (= 5 × ULN for patients with documented liver metastases). -Albumin : = 2.8 g/dL 8.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 to prior immunotherapy (e.g., immune checkpoint inhibitors) that require medical treatment or hormone replacement therapy are considered acceptable for study participation.). 9.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 last administration of the study intervention. Acceptable methods shall include barrier methods such as spermicide condoms or diaphragms. Women of childbearing potential (WOCBP) are defined as females who have experienced menarche and are not postmenopausal (including amenorrhea for at least 2 years without hormone therapy or surgical sterilization). 10.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 shall be documented: a.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 p
Exclusion criteria
Exclusion criteria: "1.History of malignancy or active malignancy other than the target disease in this study. Exceptions are as follows: a.Malignancies that have been treated with curative intent and have not recurred within the recent 2 years. b.Completely resected basal cell carcinoma or squamous cell carcinoma of the skin. c.Any type of completely resected carcinoma in situ. 2.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 administration of the study intervention can be enrolled. Note: Patients with an incidental finding of a single lesion 480 msec at screening b.Myocardial infarction, acute coronary syndrome, or history of coronary angioplasty/stenting/bypass grafting within the recent 6 months. c.Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II–IV, or a history of NYHA Class III or IV CHF. 8.Patients with significant respiratory symptoms, known or suspected serious or severe pulmonary conditions at screening, or requiring supplemental oxygen. 9.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. 10.Participation in an interventional 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 in follow-up may be enrolled if more than 3 weeks have passed since the last adm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Phase 2 dose (RP2D) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate, ORR;Duration Of Response, DOR;Disease Control Rate, DCR;Progression Free Survival, PFS;Overall Survival, OS | — |
Countries
Korea, Republic of
Contacts
Public ContactSun Young Rha
Yonsei University Health System, Severance Hospital
Outcome results
None listed