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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372NSC1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-003225-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Ami-LC-MD and Ami-LC | Experimental | 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. |
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| Part 2: Ami-HC and Ami-HC-CF | Experimental | Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ami-LC-MD | Drug | Participants will receive amivantamab admixed with rHuPH20 SC infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) | Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration. | Up to Day 29 |
| Number of Participants with Adverse Event (AE) | 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. | Up to 4 years 1 month |
| Number of Participants with Dose Limiting Toxicity (DLT) | Number of participants with DLT will be assessed. | Up to Day 28 |
| Number of Participants with Clinical Laboratory Abnormalities | Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed. | Up to 4 years 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies | Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed. | Up to 4 years 1 month |
| Epidermal Growth Factor Receptor (EGFR) Concentrations |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | West Hollywood | California | 90048 | United States | ||
| Community Health Network |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Ami-LC | Drug | Participants will receive amivantamab SC infusion. |
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| Ami-HC | Drug | Participants will receive amivantamab SC infusion. |
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| Ami-HC-CF | Drug | Participants will receive amivantamab co-formulated with rHuPH20 as SC injection. |
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EGRF concentrations markers will be assessed.
| Up to 4 years 1 month |
| Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers | cMET markers will be analyzed. | Up to 4 years 1 month |
| Overall Response Rate (ORR) | ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1. | Up to 4 years 1 month |
| Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State | Maximum amivantamab dosing interval Between time zero to steady state will be assessed. | Up to 4 years 1 month |
| Indianapolis |
| Indiana |
| 46256 |
| United States |
| Langone Health at NYC University, NYU School of Medicine | New York | New York | 10016 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Christie Nhs Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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