A Phase II, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Shanghai JMT-Bio Inc.0 sites155 target enrollmentNovember 20, 2021

ConditionsLocally Advanced or Metastatic Non-Small Cell Lung Cancer EGFR Exon20 Insertion Mutations

InterventionsJMT101 Osimertinib Mesylate Tablets

DrugsJMT101 Osimertinib Mesylate Tablets

Overview

Phase: Phase 2
Intervention: JMT101
Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: Shanghai JMT-Bio Inc.
Enrollment: 155
Primary Endpoint: Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Registry

clinicaltrials.gov

Start Date

November 20, 2021

End Date

September 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai JMT-Bio Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age≥18 years.
•Patients with non-irradiable, non-operable, histologically or cytologically confirmed Stage IIIB\~IV NSCLC, harboring an EGFR exon 20 insertion mutation (including duplication mutations), who have progressed on or intolerable to prior platinum-based chemotherapy.
•At least 1 measurable lesion according to RECIST 1.
•ECOG score 0 or
•Life expectancy≥3 months.
•Adequate organ function(tested within 7 days prior to the first dose): Absolute neutrophil count (ANC)≥1.5×10\^9 /L, Platelets≥90×10\^9/L, Hemoglobin≥9 g/dL or ≥5.6 mmol/L; Serum creatinine \<1.5 × ULN; Total bilirubin ≤1.5×ULN (if liver metastases are present,≤3×ULN), AST and ALT≤3×ULN (if liver metastases are present,≤5×ULN)；INR or PT≤1.5×ULN, APTT≤1.5×ULN.
•A female of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Any male and female patient of childbearing potential must agree to use effective contraception method throughout the trial period and for another half year after the end of the trial.
•Fully understand and fully informed of this study; must sign and give the written Informed Consent Form (ICF).

Exclusion Criteria

•Previously received monoclonal antibody therapy targeting EGFR.
•Previous chemotherapy, biotherapy, targeted therapy, immunotherapy or other anti-tumor treatment within 4 weeks prior to the first dose of the study drug, 2 weeks (or 5 half-lives whichever is longer) for using small molecule targeted drugs, 2 weeks for using radiotherapy..
•Treated with other investigational agents within 4 weeks prior to the first dose of the study drug.
•Experienced any major surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose.
•Hypersensitivity or intolerance to our study drug or any excipients of the study drug.
•Received strong or moderate inducers of CYP3A4 within 14 days prior to the first dose.
•The adverse reactions of previous antitumor treatment have not yet recovered to Grade≤ 1 based on CTCAE 5.0 or baseline (except for the toxicity without safety risk judged by the investigator, such as alopecia).
•Had untreated central nervous system metastasis or meningeal metastasis.
•History of autoimmune disease, immunodeficiency, including HIV positive, or the presence of other acquired or congenital immunodeficiency, or organ transplantation.
•Active hepatitis B, hepatitis C virus or syphilis infection.

Arms & Interventions

JMT101 in combination with Osimertinib

Intervention: JMT101

JMT101 in combination with Osimertinib

Intervention: Osimertinib Mesylate Tablets

Outcomes

Primary Outcomes

Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1

Time Frame: From the first dose to disease progression or end of study, an average of 1 year

Secondary Outcomes

Progression free survival (PFS)(From the first dose to disease progression or end of study, an average of 1 year)
Immunogenicity profile of JMT101(From the enrollment until 30 days after the last dose)
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.(From the first dose to cycle 3 day 1 (each cycle is 28 days))
Confirmed ORR Assessed by the Investigator per RECIST Version 1.1(From the first dose to disease progression or end of study, an average of 1 year)
Duration of Response (DoR)(From the first dose to disease progression or end of study, an average of 1 year)
Overall survival (OS)(From the first dose to death or end of study, an average of 1.5 years)
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0))(From the enrollment until 30 days after the last dose)
Time to maximum plasma concentration (Tmax) of JMT101.(From the first dose to cycle 3 day 1 (each cycle is 28 days))
Cl/F of JMT101.(From the first dose to cycle 3 day 1 (each cycle is 28 days))
Disease control rate (DCR)(From the first dose to disease progression or end of study, an average of 1 year)
Maximum measured plasma concentration (Cmax) of JMT101.(From the first dose to cycle 3 day 1 (each cycle is 28 days))
Half-life (T1/2) of JMT101.(From the first dose to cycle 3 day 1 (each cycle is 28 days))
Detection of cancer-related biomarkers in circulating tumor DNA from plasma to analyse the corcorrelation with clinical efficacy and drug resistance.(From the enrollment to disease progression, an average of 1 year)