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

NCT05158491 | Unknown Phase 1

• 1 other identifier: JK-1201I-201
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Small Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (2)

• To determine dose limited toxicity (DLT) of JK-1201I in patients with SCLC.

  Dose limited toxicity in SCLC patients will be determined. DLT is defined as: 1..Grade 4 neutropenia (ANC) reduction lasts ≥3 days; or grade 3 ANC reduction with fever (ANC \<1000 / mm3 with oral temperature single measurement\> 38.3 ℃ or ≥38.0 ℃ for 1 hour)； 2. Grade 3 thrombocytopenia (25×109/L≤ platelet count \< 50×109/L) with obvious clinical bleeding symptoms, or grade 4 thrombocytopenia (with or without obvious clinical bleeding symptoms); 3. Other grade 4 hematological toxicity； 4. Grade 3 and above non-hematological toxicity； 5. Hair loss, fatigue, except for those with grade 3 nausea, vomiting, and diarrhea without maximum symptomatic supportive treatment.

  21days

• To determine the maximum tolerance dose level of JK-1201I in patients with SCLC.

  MTD is defined as the highest dose that can be given without causing any adverse side effects according to CTCAE v5.0.

  21days

Secondary Outcomes (3)

• To measure the highest plasma concentrations of JK-1201I in patients with SCLC.

  21 days

• To determine the exposure levels of JK-1201I in SCLC patients

  21 days

• To examine the primary efficacy of JK-1201I in treating patients with SCLC.

  21days

Study Arms (4)

180 mg/mm2

ACTIVE COMPARATOR

Subjects will be dosed at 180 mg/mm2 level.

Drug: JK-1201I

220 mg/mm2

ACTIVE COMPARATOR

Subjects will be dosed at 220 mg/mm2 level.

Drug: JK-1201I

260 mg/mm2

ACTIVE COMPARATOR

Subjects will be dosed at 260 mg/mm2 level.

Drug: JK-1201I

300 mg/mm2

ACTIVE COMPARATOR

Subjects will be dosed at 300 mg/mm2 level.

Drug: JK-1201I

Interventions

JK-1201I DRUG

JK-1201I will be given every 3 weeks, maximum of 4 treatment cycle.

Also known as: PEG-Irinotecan

180 mg/mm2; 220 mg/mm2; 260 mg/mm2; 300 mg/mm2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the age of 18 to 70, male or female;
• Diagnosed having SCLC via either histology or cytology;
• Extensive small-cell lung cancer with recurrence or progression within ≤6 months from the end of first-line therapy;
• At least one measurable lesion (non-intracranial, non-measurable after radiotherapy) according to RECIST version 1.1;.
• ECOG-PS score is 0-1;
• Expected survival time ≥12 weeks;
• Have faverable organ and hematopoietic function, with no serious abnormality of heart, lung, liver or kidney function or immune deficiency according to laboratory tests:
• 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.
• Voluntarily participate in the clinical study and sign the informed consent

You may not qualify if:

• Have a previous history of allergy, or are known to be severely allergic to either JK1201I or its excipients;
• Previous treatment with topoisomerase I inhibitor (such as irinotecan, topotecan, etc.);
• At the first use of the drug in this study, other anti-tumor chemotherapy or immunotherapy was stopped for \< 4 weeks;
• CYP3A4 strong inducer was used within 2 weeks before the first administration, or CYP3A4 suppressor or UGT1A1 suppressor was used within 1 week;
• 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));
• 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;
• 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);
• 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.);
• 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;
• 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;
• large amounts of pleural effusion and ascites needed to be treated (continuous pleural and abdominal effusion \> 1000ml within 1 week);
• 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;
• Pregnant or breast-feeding women;
• Presence of human immunodeficiency virus (HIV) or active hepatitis b (HBsAg positive and HBV-DNA titer ≥1x103 copy number /mL or 200IU/ mL;
• Subjects who have participated in other clinical trials within 4 weeks prior to obtaining informed consent;

Sponsors & Collaborators

• JenKem Technology Co., Ltd.: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 1000142, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

etirinotecan pegol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xuan Zhao, Ph.D.

  JenKem Technology Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Xuan Zhao, Ph.D.

CONTACT

86-10-82156767; xuanzhao@jenkem.com

Xiaoping Wang, Ph.D.

CONTACT

86-18701057976; xiaopingwang@jenkem.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 15, 2021
• Study Start: November 11, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)