EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer

Part of paid clinical trials in Orange, California.

Sponsor
Shanghai EpimAb Biotherapeutics Co., Ltd.
Study ID
NCT05498389
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Lung Non-Small Cell Carcinoma
  • EGFR Mutation-Related Tumors
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EMB-01 — DRUG
    EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).
  • Osimertinib — DRUG
    Osimertinib is an approved, third-generation EGFR tyrosine kinase inhibitor

Study Details

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.

Key Dates

Start date
Jun 30, 2023
Status verified
May 2023
Primary completion
Jul 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II)
    In Part 1 dose escalation, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached, or all planned doses are administered. In Part 2 dose expansion, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28 at the recommended phase II dose (RP2D) regimen. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of EMB-01 and osimertinib (Phase Ib only) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California Irvine School of MedicineOrangeCalifornia92868
Misako Nagasaka
[email protected]
Dana-Farber Cancer InstituteBostonMassachusetts02215
Julia Kathleen Rotow
[email protected]

Find similar trials in Orange, CA

By research site
Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine· Orange, CADana-Farber Cancer Institute· Boston, MA

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