Ami-LC-MD
DrugParticipants will receive amivantamab admixed with rHuPH20 SC infusion.
NCT Number: NCT04606381
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
University Health Network, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive amivantamab admixed with rHuPH20 SC infusion.
Participants will receive amivantamab SC infusion.
Participants will receive amivantamab SC infusion.
Participants will receive amivantamab co-formulated with rHuPH20 as SC injection.
Time frame: Up to Day 29
Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.
Time frame: Up to 4 years 1 month
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time frame: Up to Day 28
Number of participants with DLT will be assessed.
Time frame: Up to 4 years 1 month
Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
Time frame: Up to 4 years 1 month
Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed.
Time frame: Up to 4 years 1 month
EGRF concentrations markers will be assessed.
Time frame: Up to 4 years 1 month
cMET markers will be analyzed.
Time frame: Up to 4 years 1 month
ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 4 years 1 month
Maximum amivantamab dosing interval Between time zero to steady state will be assessed.
Janssen Research & Development, LLC
Industry
An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies
Acronym: PALOMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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