A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04606381|
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : November 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Malignancies||Drug: Ami-LC-MD Drug: Ami-LC Drug: Ami-HC Drug: Ami-HC-CF||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 10, 2020|
|Estimated Primary Completion Date :||April 3, 2023|
|Estimated Study Completion Date :||December 29, 2024|
Experimental: Part 1: Ami-LC-MD and 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.
Participants will receive amivantamab admixed with rHuPH20 SC infusion.
Participants will receive amivantamab SC infusion.
Experimental: Part 2: Ami-HC and 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).
Participants will receive amivantamab newly developed high concentration SC infusion.
Participants will receive amivantamab co-formulated with rHuPH20.
- Observed Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) [ Time Frame: Up to Day 29 ]Ctrough is the observed serum concentration immediately prior to the next drug administration.
- Number of Participants with Adverse Event (AE) [ Time Frame: Up to 3 years and 10 months ]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.
- Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]Number of participants with DLT will be assessed.
- Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to 3 years and 10 months ]Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
- Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies [ Time Frame: Up to 3 years and 10 months ]Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed.
- Epidermal Growth Factor Receptor (EGFR) Concentrations [ Time Frame: Up to 3 years and 10 months ]EGRF concentrations markers will be assessed.
- Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers [ Time Frame: Up to 3 years and 10 months ]cMET markers will be analyzed.
- Overall Response Rate (ORR) [ Time Frame: Up to 3 years and 10 months ]ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1.
- Maximum Dosing Interval Between Time Zero to Steady State [ Time Frame: Up to 3 years and 10 months ]Maximum dosing interval Between time zero to steady state will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606381
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|United States, California|
|Cedars Sinai Medical Center||Not yet recruiting|
|West Hollywood, California, United States, 90048|
|United States, Indiana|
|Community Health Network||Not yet recruiting|
|Indianapolis, Indiana, United States, 46256|
|United States, New York|
|Langone Health at NYC University, NYU School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|United States, Oregon|
|Providence Portland Medical Center||Not yet recruiting|
|Portland, Oregon, United States, 97213|
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Korea, Republic of|
|Severance Hospital, Yonsei University Health System||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|The Christie Nhs Foundation Trust||Recruiting|
|Manchester, United Kingdom, M20 4BX|
|Royal Marsden Hospital||Recruiting|
|Sutton, United Kingdom, SM2 5PT|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|