Ph II Subcutan Amivantamab in Pts w/ Adv or Metastat SolidTumors EGFR-mutated Non-Small Cell Lung Ca

Cancer
Misako Nagasaka
A Phase II, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Ill-Defined Sites
Kaposis sarcoma
Kidney
Larynx
Lip Oral Cavity and Pharynx
Liver
Lung
Melanoma skin
Mycosis Fungoides
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

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Eligibility

Inclusion

-Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC)

  • articipants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

-May have a prior or concurrent second malignancy

-Have adequate organ

-A participant must agree not to donate eggs (ova, oocytes) or freeze for future use

Exclusion

-Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis

-Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort

-Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1.

-Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5)

-Other clinically active liver disease of infectious origin

-Participant has a history of clinically significant cardiovascular disease

-Participant has symptomatic brain metastases

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