A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malig… (NCT04606381) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
United States158 participantsStarted 2020-11-10
Plain-language summary
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Part 1 and Part 2: Participant must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and which may derive benefit from epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transition tyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy. Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (CRC), renal cell cancer (RCC), medullary thyroid cancer (MTC), gastroesophageal cancer (GEC), mesothelioma, breast cancer (BC) and ovarian cancer (OC). Participants must have either progressed after prior standard of care therapy for metastatic disease, be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
* A man who is sexually act…
What they're measuring
1
Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
Timeframe: Up to Day 29
2
Number of Participants with Adverse Event (AE)
Timeframe: Up to 4 years 1 month
3
Number of Participants with Dose Limiting Toxicity (DLT)
Timeframe: Up to Day 28
4
Number of Participants with Clinical Laboratory Abnormalities