Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.
The Phase I Clinical Study of the Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine BMD006 in Patients With Advanced Lung Cancer or Metastatic Solid Tumors in the Lungs.
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of participants experiencing dose-limiting toxicities（DLTs）
Time frame: about 2 years
Determine the maximum tolerated dose（MTD） of BMD006
Time frame: about 2 years
Determine the recommended phase II dose (RP2D) for the clinical study.
Time frame: about 2 years
number of participants experiencing adverse events（AEs）
Time frame: about 2 years
Secondary Endpoints
overall response rate（ORR）
Disease Control Rate(DCR)
Duration of Response(DOR)
Eligibility Criteria
Inclusion Criteria: * Able to understand and comply with the requirements of the study protocol, voluntarily participate in the trial, and sign a written informed consent form (ICF). * Must be at least 18 (inclusive) at the time of signing the ICF, and both male and female participants are eligible. * Histologically or cytologically confirmed as advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis, and having failed prior standard treatments or having no standard treatment options. * Agree to provide fresh tumor tissue samples or archived tumor tissue samples within the past three years. * Presence of at least one measurable lesion as defined by RECIST V1.1 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 * Organ function must be adequate at screening (no need for blood transfusion, hematopoietic growth factors, human albumin, or medications for correction within 14 days prior to first treatment), specifically defined as: a)…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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