A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanc… (NCT05482568) | Clinical Trial Compass
RecruitingPhase 1/2
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
China324 participantsStarted 2022-09-15
Plain-language summary
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
✓. When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
✓. The ECOG score is 0 or 1
✓. The expected survival is ≥12 weeks
✓. Subjects with advanced or metastatic non-small cell lung cancer
✓. Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided
✓. Subjects who have failed prior standard care or are intolerant to standard care
✓. There is at least one measurable lesion
Exclusion criteria
✕. There are untreated or active central nervous system (CNS) tumor metastases
✕. Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
✕. Systemic antitumor therapy was performed 4 weeks prior to study initiation
✕. Prior treatment with antibody-conjugated drugs
✕
What they're measuring
1
DLT(Phase I (dose exploration phase) main study endpoint)
Timeframe: 21 days after the first administration of each subject
2
AE(Phase I (dose exploration phase) main study endpoint)
Timeframe: Two years after the last subject was enrolled in the group
3
Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)
Timeframe: Two years after the last subject was enrolled in the group
4
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Timeframe: Two years after the last subject was enrolled in the group
. Received \>30 Gy chest radiation within 6 months prior to initial administration
✕. Palliative radiotherapy was completed within 7 days prior to initial administration
✕. Failure to recover from toxicity and/or complications of previous interventions to nCI-CTCAE ≤1
✕. The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected