Ph II Subcutan Amivantamab in Pts w/ Adv or Metastat SolidTumors EGFR-mutated Non-Small Cell Lung Ca

UCI Specialty Area: Cancer

Principal Investigator: Misako Nagasaka

Official Title: A Phase II, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer

A Study On:

Anus

Bones and Joints

Brain and Nervous System

Breast

Cervix

Colon

Corpus Uteri

Esophagus

Eye and Orbit

Ill-Defined Sites

Kaposis sarcoma

Kidney

Larynx

Lip Oral Cavity and Pharynx

Liver

Lung

Melanoma skin

Mycosis Fungoides

Other Digestive Organ

Other Endocrine System

Other Female Genital

Other Male Genital

Other Respiratory and Intrathoracic Organs

Other Skin

Other Urinary

Ovary

Pancreas

Prostate

Rectum

Small Intestine

Soft Tissue

Stomach

Thyroid

Unknown Sites

Urinary Bladder

Study Description

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Eligibility

Inclusion

-Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC)

articipants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

-May have a prior or concurrent second malignancy

-Have adequate organ

-A participant must agree not to donate eggs (ova, oocytes) or freeze for future use

Exclusion

-Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis

-Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort

-Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1.

-Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5)

-Other clinically active liver disease of infectious origin

-Participant has a history of clinically significant cardiovascular disease

-Participant has symptomatic brain metastases

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

What is an IRB?