EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer (NCT05498389) | Clinical Trial Compass
UnknownPhase 1/2
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer
United States, China115 participantsStarted 2023-06
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
✓. Age ≥ 18 years
✓. ECOG ≤ 1
✓. Patients with histologically or cytologically confirmed advanced/metastatic EGFR-mutant NSCLC
✓. Patients must have measurable or evaluable disease per RECIST v1.1.
✓. Patients must be willing to submit a blood sample for gene alteration analysis by next generation sequencing (NGS).
✓. Archival tumor tissue (formalin-fixed paraffin-embedded) or a new biopsy is required prior to initiation of the study treatment for biomarker analysis.
✓. Phase Ib a. Patients who have progressed on/after standard therapy and no other therapies are available Phase II
Exclusion criteria
✕. Life expectancy \< 3 months
What they're measuring
1
Maximum tolerated dose (MTD) of EMB-01 and osimertinib (Phase Ib only)
Timeframe: Up to 28 days
2
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Timeframe: From enrollment up to 30 days after the last dose
3
Recommended phase II dose (RP2D) of EMB-01 and osimertinib (Phase Ib)
Timeframe: Up to 28 days
4
Objective Response Rate (ORR) (Phase II only)
Timeframe: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
. Any remaining AE \> grade 1 as per CTCAE v5.0 from prior anticancer therapy with the exceptions of alopecia, ≤ grade 2 fatigue, ≤ grade 2 peripheral neuropathy, and grade ≤ 2 hypothyroidism stable on hormone replacement therapy. Patients who were prior treated with osimertinib or another 3rd-generation EGFR TKI, EMB-01 monotherapy, or another EGFR/cMET bispecific antibody and experienced a toxicity that led to permanent discontinuation or dose reduction will be excluded. Note: Exceptions are possible, on a case-by-case basis following discussion and mutual agreement between Investigator and Sponsor.
✕. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of the Investigator or if radiation therapy for CNS metastases is completed ≥4 weeks prior to study treatment.
✕. Patients with a history of clinically significant cardiovascular disease including:
✕. History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis