JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy
NCT ID: NCT05164848
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2021-12-25
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A
JMT101 combined with two dose levels of afatinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
JMT101
JMT101 will be administered intravenously at 6 mg/kg every 2 weeks (q2w) in each 28-week cycle.
Afatinib
Afatinib will be administered orally at 30 mg or 40 mg per day (qd) in each 28-week cycle.
Dose Expansion Cohort
Once the safe and effective dose has been determined, an expansion cohort will be recruited to further evaluate the efficacy and safety of the selected dose.
JMT101
JMT101 will be administered intravenously at 6 mg/kg every 2 weeks (q2w) in each 28-week cycle.
Afatinib
Afatinib will be administered orally at 30 mg or 40 mg per day (qd) in each 28-week cycle.
Interventions
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JMT101
JMT101 will be administered intravenously at 6 mg/kg every 2 weeks (q2w) in each 28-week cycle.
Afatinib
Afatinib will be administered orally at 30 mg or 40 mg per day (qd) in each 28-week cycle.
Eligibility Criteria
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Inclusion Criteria
2. Histological or cytologically confirmed esophageal squamous cell carcinoma;
3. Patients with metastatic disease or locally advanced disease (UICC or AJCC 8th Edition) unsuitable for radical surgery or radiotherapy; with direct invasion of adjacent organs (such as aorta or trachea) (T4b) should be closely assessed for the risk of bleeding before enrollment;
4. Patients who have failed first-line or above treatments. The treatment failure is defined as disease progression or intolerable toxicity during or after the last dose of systemic standard chemotherapy, and recurrence or metastasis during treatment or within 6 months of discontinuation of radical therapy including radical concurrent chemoradiotherapy and neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy);
5. At least 1 measurable lesion according to RECIST 1.1 at baseline; if there is only one measurable lesion at baseline, the area must have not had prior radiotherapy or there must be evidence of apparent progression after radiotherapy;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
7. Life expectancy exceeds 3 months;
8. The function of major organs and bone marrow meet the following criteria within 7 days before treatment (No blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), or other support therapy within 7 days prior to administration of the study drug):
Blood routine: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥80×10\^9/L, hemoglobin ≥80 g/L; Kidney function test: Serum creatinine ≤1.5×upper limit of normal (ULN); Liver function tests: total bilirubin ≤1.5×ULN (≤3×ULN for patients with liver metastasis), aspartate aminotransferase ( AST) and alanine aminotransferase (ALT ) ≤3×ULN ( ≤5×ULN for patients with liver metastasis); Blood coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
9. The fertile women should have a negative blood pregnancy test within 7 days before enrollment; fertile men or women must agree to use effective contraceptive methods during the whole trial period and six months after the last administration;
10. Patients fully understand and voluntarily participate in this study and sign informed consent.
Exclusion Criteria
2. Patients whose tumor has invaded important blood vessels or is much more likely to invade important blood vessels and cause fatal hemorrhage during the study according to the investigator's judgement; patients who have hemorrhage in the lung or other parts, have a bleeding tendency, or are receiving thrombolytic or anticoagulant therapy;
3. Anti-tumor therapy such as chemotherapy, biological therapy, targeted therapy, immunotherapy, etc. within 4 weeks before the first administration of the study drug; oral small molecule targeting drugs within 2 weeks of the first dose or within the 5 half-life of known drugs (whichever is longer); radiotherapy within 2 weeks before the first administration of the study drug;
4. Received other investigational product within 4 weeks before the first administration of the study drug;
5. Received major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before the first administration of the study drug;
6. Received strong inducers and strong inhibitors of P-gp within 2 weeks before the first administration of the study drug;
7. Uncontrolled cancer pain; not at a stable dose of anesthetic analgesics at the time of enrollment.
8. Adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ grade 1 according to CTCAE 5.0 (except for the toxicity without safety risk judged by investigator, such as alopecia);
9. Central nervous system metastasis or meningeal metastasis;
10. History of autoimmune disease or immunodeficiency disease including human immunodeficiency virus antibody (HIV-Ab) positive, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
11. Active hepatitis B, active hepatitis C, or positive for treponema pallidum antibodies;
12. History of severe cardiovascular disease;
13. History of other malignancies within 5 years before the first administration of the study drug, except: malignant lesions that have been treated with therapeutic measures and no known active lesions within 5 or more years before enrolment, and are judged by the treating physician to be at low risk of recurrence; adequately treated non-melanoma skin cancer and cervical cancer in situ without evidence of progression; or prostatic intraepithelial neoplasia without evidence of recurrence of prostate cancer.
14. Patients with any severe or uncontrollable disease are unsuitable to participate in this clinical trial according to the investigator's judgement;
15. Known hypersensitivity or intolerance to any component of the study drug or its excipients;
16. Past or present interstitial pneumonia/pulmonary disease;
17. Pregnant or lactating women;
18. Other situations that may increase the risks related to the study drug or affect compliance of the trial compliance are not suitable for the trial as determined by the investigator.
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Shen Lin
Clinical Professor
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Anhui Provincial Hospital
Hefei, Hefei, China
Henan Cancer Hospital
Henan, Henan, China
Xinxiang Central Hospital of Henan Province
Xingxiang, Xingxiang, China
Countries
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Central Contacts
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Facility Contacts
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Lin Shen
Role: primary
Yongsheng Li
Role: primary
Dong Qian
Role: primary
Suxia Luo
Role: primary
Chunqing Li
Role: primary
Other Identifiers
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JMT101-CSP-004
Identifier Type: -
Identifier Source: org_study_id