PhI/II Study of MCLA-129 in Pts w/Adv NSCLC & Other Solid Tumors

Cancer
Sai-Hong Ou
Phase I/II 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
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Ill-Defined Sites
Kaposis sarcoma
Kidney
Larynx
Leukemia other
Lip Oral Cavity and Pharynx
Liver
Lung
Melanoma skin
Mycosis Fungoides
Myeloid and Monocytic Leukemia
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder

Study Description

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 as monotherapy in patients with NSCLC, or HNSCC or other solid tumors and who have progressed after receiving prior therapy for advanced/metastatic disease.

Eligibility

Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced unresected disease that is incurable.

Patients with NSCLC or other solid tumors 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.

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.

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.

Prior treatment with a bispecific EGFR-c-MET antibody.

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.

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.

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