Safety, Tolerability and Preliminary Efficacy of JK1201I in Patients With SCLC

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to evaluate the safety, tolerability and primary efficacy of JK-1201I in patients with small cell lung cancer (SCLC)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JenKem Technology Co., Ltd.
• Collaborator: Beijing Cancer Hospital
• Treatments: Irinotecan

Criteria

Inclusion Criteria:

1. Between the age of 18 to 70, male or female;

2. Diagnosed having SCLC via either histology or cytology;

3. Extensive small-cell lung cancer with recurrence or progression within ≤6 months from the end of first-line therapy;

4. At least one measurable lesion (non-intracranial, non-measurable after radiotherapy) according to RECIST version 1.1;.

5. ECOG-PS score is 0-1;

6. Expected survival time ≥12 weeks;

7. Have faverable organ and hematopoietic function, with no serious abnormality of heart, lung, liver or kidney function or immune deficiency according to laboratory tests:

8. Fertile male subjects and female subjects of reproductive age who are willing to take effective non-drug contraceptive measures from signing the informed consent form until 6 months after the last administration of the study drug. Blood pregnancy test results of women of childbearing age must be negative within 7 days before the first trial drug administration.

9. Voluntarily participate in the clinical study and sign the informed consent

Exclusion Criteria:

1. Have a previous history of allergy, or are known to be severely allergic to either JK1201I or its excipients;

2. Previous treatment with topoisomerase I inhibitor (such as irinotecan, topotecan, etc.);

3. At the first use of the drug in this study, other anti-tumor chemotherapy or immunotherapy was stopped for < 4 weeks;

4. CYP3A4 strong inducer was used within 2 weeks before the first administration, or CYP3A4 suppressor or UGT1A1 suppressor was used within 1 week;

5. Patients with clinically serious gastrointestinal dysfunction (positive fecal ocidiocytic blood and severe gastrointestinal bleeding, gastrointestinal infection, obstruction or grade 1 or above diarrhea (increase of stool number ≥4 times per day));

6. Complicated with symptomatic brain metastasis, meningeal metastasis, spinal tumor invasion, spinal cord compression; Superior vena cava syndrome, obstructive atelectasis, and bone metastasis with local symptoms that may require non-medical treatment such as radiotherapy/surgery/endoscopic therapy/interventional therapy;

7. For patients with brain metastasis (the distance from the end of whole brain radiotherapy to the first dose ≤7 days, and the distance from the end of SBRT radiotherapy to the first dose ≤3 days);

8. Patients with severe heart disease within 6 months prior to enrollment, such as unstable angina, heart failure (New York Heart Association Heart function classification > Class II), coronary angioplasty or stenting, deep vein thrombosis, myocardial infarction, etc.; Or other diseases that may affect the subject's safety, such as deep vein thrombosis, stroke, stroke (except caval infarction), poorly controlled active bleeding or known bleeding constitution, etc.);

9. Had a serious pulmonary disease, such as pulmonary fibrosis, active pulmonary tuberculosis, pulmonary hypertension, etc., within 6 months prior to inclusion;

10. Other malignant tumors occurred within 5 years before enrollment, except carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell carcinoma which had been treated for radical treatment before;

11. UGT1A1 suppressor (azanavir, giferozil, etc.) was used or had been used in combination drugs or within 7 days prior to the treatment of the study drugs;

12. large amounts of pleural effusion and ascites needed to be treated (continuous pleural and abdominal effusion > 1000ml within 1 week);

13. Toxicity of previous anti-tumor therapy (including chemotherapy/radiotherapy, surgical therapy, targeted therapy, immunotherapy, Chinese herbal therapy, endocrine therapy or other anti-tumor therapy) has not recovered (grade 1 or above as assessed by CTCAE version 5.0, Except for hair loss, alkaline phosphatase, glutamyltranspeptidase (GGT), or subjects eligible for inclusion after discussion with the investigator and sponsor);

14. Subjects with severe infection within 4 weeks before the first medication, including but not limited to those with infectious complications, bacteremia and severe pneumonia requiring hospitalization;

15. Pregnant or breast-feeding women;

16. Presence of human immunodeficiency virus (HIV) or active hepatitis b (HBsAg positive and HBV-DNA titer ≥1x103 copy number /mL or 200IU/ mL;

17. Subjects who have participated in other clinical trials within 4 weeks prior to obtaining informed consent;

18. Have a clear history of mental disorders;

19. Subjects considered unsuitable for the study by the investigator for other reasons.