Study of ST-1898 in Advanced Renal Cell Carcinoma

Launched by BEIJING SCITECH-MQ PHARMACEUTICALS LIMITED · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ST-1898 for patients with advanced renal cell carcinoma (RCC), which is a type of kidney cancer. The trial aims to find out how safe and effective ST-1898 is, as well as the best dose for patients. In the first part of the study, researchers will look at how well patients tolerate the medication and how it is processed in the body. In the second part, they will focus on how well the treatment works in shrinking tumors.

To be eligible for the trial, participants must be at least 18 years old, have advanced RCC that has not responded to standard treatments, and be able to provide a sample of their tumor tissue. They should also be in good overall health, with certain blood and organ function levels. Participants will take ST-1898 in pill form and will be monitored closely by the medical team. It's important to note that certain health conditions and recent treatments may prevent someone from joining the study. Overall, this trial offers hope for new treatment options for patients with advanced kidney cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>= 18 years
• • 2. Life expectancy of three months or more
• • 3. Diagnosis of advanced renal cell carcinoma (RCC) by histopathology and medical imaging, standard treatment failure or no standard treatment regimen available
• • 4. With agreement to provide a tumor tissue specimen
• • 5. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol
• • 6. Has at least one measurable lesion as defined by RECIST version 1.1
• • 7. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
• 8. Has adequate organ function defined as follows:
• • 1. Bone marrow : absolute neutrophil count ≥ 1,500/µL, Hgb level ≥ 90 g/L and platelet count (Plt) i. ≥ 90x109/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening;
• • 2. Liver: transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin i. (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease
• • 3. Kidney: Creatinine ≤1.5 ULN, protein in urine ≤1+, if ≥2+ but \<1g within 24h
• • 4. Heart: LVEF≥50%
• • 5. Coagulation function: INR≤1.5×ULN，APTT≤1.5×ULN
• • 9. Women of child bearing potential must have a negative serum pregnancy test within 7 days before first study drug administration. Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration.
• Exclusion Criteria:
• • 1. Has received another anti-tumor therapy within two weeks or within 5 half-life of anti- tumor drug prior to the first dose
• • 2. Has had major surgery within 4 weeks before the first study drug administration (except tumor biopsy, puncture, invasive dental procedures such as tooth extraction, dental implants etc.)
• • 3. Current or previous severe retinopathy who, in the judgment of the Investigator or specialist, are not suitable for enrollment
• 4. Has had any history of major cardiovascular event within 6 months prior to study drug administration including but not limited to :
• • 1. Serious arrhythmia or cardiac conduct abnormality , such as degree II-III atrioventricular block or ventricular arrhythmia needs to be treated
• • 2. QTc interval extension: male \>450 ms, female \>470 ms
• • 3. Acute coronary syndrome, stroke, deep vein thrombosis, pulmonary- thromboembolism, arterial thrombosis, congestive heart failure, aortic dissection etc.
• • 4. New York Heart Association Class ≥ II
• • 5. Has uncontrolled hypertension, as defined by a sustained blood pressure (BP) \> 140/90 mHg with antihypertensive treatment
• • 5. Has brain metastases with symptoms or with evidence of progression
• • 6. Has Interstitial lung disease or radiation pneumonia requiring treatment by steroid
• • 7. Has a prior or concomitant invasive malignancy other than RCC with the exception of adequately treated non-melanoma skin cancer, breast cancer in situ ,cervical carcinoma in situ or superficial bladder cancer any other malignancy from which the patient has remained disease free within the past 5 years
• • 8. Has ≥ grade 3 hemorrhage/bleeding event within 6 months prior to study drug administration or currently ≥ grade 2 hemorrhage or event of high risk of hemorrhage ) including active gastritis/duodenal ulcer or esophageal varices
• • 9. Within 2 weeks prior to study drug administration, receiving chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors
• • 10. Has not recovered from toxicities caused by prior therapy to CTCAE≤ Grade 1 (except for peripheral neuropathy becoming ≤Grade 2, alopecia, and other events judged tolerable by the Investigator and without safety risks).
• • 11. Active hepatitis B (asymptomatic hepatitis B carriers with HBV DNA \< 2000 IU/mL are allowed to be enrolled), hepatitis C virus (HCV) antibody-positive and HCV-RNA- positive, or other active hepatitis, clinically significant moderate-to-severe cirrhosis, are allowed to receive prophylactic antiviral therapy other than interferon.
• • 12. Has acute bacterial, viral or fungal infections, requiring systemic anti-infective treatment.
• • 13. HIV positive
• • 14. Pregnant or lactating females
• • 15. Drug or alcohol dependents
• • 16. Has significant disorder of neurology or mental disease or poorly compliance
• • 17. Unable to swallow oral medications or condition or conditions that in the judgment of the Investigator which severely interfere with gastrointestinal absorption, such as dysphagia, intestinal obstruction, etc.
• • 18. Clinically uncontrollable third interstitial effusion that, in the judgment of the Investigator, is unsuitable for enrollment.
• • 19. Has a history of other serious systemic disease, or any other reason that might interfere with participation in trial or interfere with interpretation of trial results, in the judgement of the Investigator, that are not qualified to participate in this trial.