Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Sai-Hong I Ou, MD

Description

Summary

A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.

Official Title

Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

Keywords

Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, MCLA-129, EGFR inhibitor, NSCLC, C-MET, GC/GEJ, Head and Neck Cancer, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Osimertinib, Chemotherapy

Eligibility

For people ages 18 years and up

Part One: Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens.

Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator.

  • Availability of archival or a fresh tumor tissue sample.
  • Measurable disease as defined by RECIST version 1.1 by radiologic methods.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks, as per Investigator.
  • Adequate organ function (as per protocol)

Exclusion Criteria:

  • Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry.
  • Known leptomeningeal involvement.
  • Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
  • Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.
  • Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible.
  • Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed.
  • History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents. History of hypersensitivity reaction or any toxicity attributed to chemotherapy and components.
  • History of clinically significant cardiovascular disease
  • Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD or pneumonitis.
  • Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug.
  • Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
  • Active Hepatitis B infection without receiving antiviral treatment.
  • Positive test for Hepatitis C
  • Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral load are allowed. In

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • START Mountain Region accepting new patients
    West Valley City Utah 84119 United States

Lead Scientist at UC Irvine

  • Sai-Hong I Ou, MD
    Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 11 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merus N.V.
ID
NCT04868877
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 576 study participants
Last Updated