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
Details
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
You can join if...
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