A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
- Conditions
- Advanced Solid Malignancies
- Interventions
- Registration Number
- NCT04606381
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 159
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: Ami-HC and Ami-HC-CF Ami-HC-CF Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or amivantamab co-formulated with rHuPH20 (Ami-HC-CF). Part 1: Ami-LC-MD and Ami-LC Ami-LC-MD Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion. Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ Lazertinib Ami-HC-CF Participants will receive SC infusion of either Ami-HC-CF or Ami-HC in combination with lazertinib tablet. Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ Lazertinib Ami-HC Participants will receive SC infusion of either Ami-HC-CF or Ami-HC in combination with lazertinib tablet. Part 2: Ami-HC and Ami-HC-CF Ami-HC Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or amivantamab co-formulated with rHuPH20 (Ami-HC-CF). Part 1: Ami-LC-MD and Ami-LC Ami-LC Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion. Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ Lazertinib Lazertinib Participants will receive SC infusion of either Ami-HC-CF or Ami-HC in combination with lazertinib tablet.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicity (DLT) Up to Day 28 Number of participants with DLT will be assessed.
Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) Up to Day 29 Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.
Number of Participants with Adverse Event (AE) 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.
Amivantamab Steady-state Area Under the Curve (AUCss) Cycle 4 (28 days) AUCss is defined as the area under the curve for amivantamab at steady state.
Number of Participants with Clinical Laboratory Abnormalities Up to 4 years 1 month Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
- Secondary Outcome Measures
Name Time Method Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers Up to 4 years 1 month cMET markers will be analyzed.
Epidermal Growth Factor Receptor (EGFR) Concentrations Up to 4 years 1 month EGRF concentrations markers will be assessed.
Overall Response Rate (ORR) 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.
Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies Up to 4 years 1 month Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed.
Part 3: Plasma Concentration of Lazertinib Up to 4 years 1 month Plasma samples will be analyzed to determine concentrations of lazertinib using a validated method.
Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State Up to 4 years 1 month Maximum amivantamab dosing interval Between time zero to steady state will be assessed.
Trial Locations
- Locations (12)
University Health Network
🇨🇦Toronto, Ontario, Canada
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
The Christie Nhs Foundation Trust
🇬🇧Manchester, United Kingdom
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Langone Health at NYC University, NYU School of Medicine
🇺🇸New York, New York, United States
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Cedars Sinai Medical Center
🇺🇸West Hollywood, California, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of