A Study of SKLB1028 in Patients With Advanced Solid Tumor

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Criteria

Inclusion Criteria:

• Patients volunteered to participate in this study and signed the informed consent form.

• Age ≥18, no gender limitation.

• Patients with malignant solid tumor who have failed or could not tolerate standard treatment and for whom no standard treatment is available.

• Recurrent or metastatic solid tumors confirmed by histology; patients who are judged by the investigator to be suitable for treatment with SKLB1028 capsules and who meet the requirements of tumor type for corresponding stages:

1. Stage I: no restriction on solid tumor types;

2. Phase II: solid tumor type determined by the investigator and the sponsor based on the results of phase I.

• Stage 1: At least one unmeasurable lesion; Stage 2: At least one measurable lesion according to RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Patient must meet the following criteria as indicated on the clinical laboratory tests:

1. Absolute neutrophil count ≥1.5×10^9 /L; platelet count ≥80×10^9 /L; hemoglobin ≥90 g/L;

2. Serum creatinine ≤ 1.5 × upper limit of normal (ULN);

3. Total bilirubin ≤ 1.5 × ULN, (≤ 3 × ULN for patients with liver metastasis or liver cancer); Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastasis or liver cancer).

• Patient is suitable for oral administration of the study drug.

• Female patients should agree to use contraceptive measures (such as IUD, condom, etc.) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 7 days prior to enrollment and must be non-lactating patients; male patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

• The patient have a previous history of severe allergy to drugs and food.

• Expected survival < 3 months.

• Other malignant active tumors within the past 3 years; except for cured locally curable cancers, such as basal or squamous cell skin carcinoma, or in situ prostate, cervical or breast cancer.

• Central nervous system metastasis (excluding brain metastasis with stable symptoms after local treatment)

• Patients with hepatitis B (HBsAg positive or HBcAb positive with HBV DNA higher than the upper limit of the normal value of the research center) or hepatitis C (HCV antibody positive with HCV RNA higher than the upper limit of the normal value of the research center) or HIV antibody positive.

• Patients whose toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1.

• Cardiac dysfunction, including:

QTc interval female ≥ 470 ms, male ≥ 450 ms; Complete left bundle branch block, grade II or III atrioventricular block; Poorly controlled malignant arrhythmias; Cardiac valve regurgitation or stenosis requiring treatment; Cardiac ejection fraction less than 50% within 6 months before screening; Myocardial infarction, unstable angina pectoris, severe pericardial disease, severe myocardial disease occurred within 6 months before screening; History of chronic congestive heart failure with NYHA ≥ grade 3.

• Patients have poorly controlled hypertension.

• Patients have thrombotic or embolic events such as cerebrovascular accident, pulmonary embolism, etc within 6 months before screening.

• Patients who have received any antitumor treatment within 4 weeks before the first administration; those who have received herbal or proprietary Chinese medicines with a clear antineoplastic indication 2 weeks prior to the first administration.

• Patients have received other unlisted clinical study drugs within 4 weeks before the first administration.