Could a simple shot replace IV drips for some cancer patients?
NCT ID NCT04606381
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This early-stage trial is testing whether amivantamab, a drug that targets specific proteins on cancer cells, can be given as a shot under the skin instead of through an IV. About 158 adults with advanced solid tumors (like lung or head and neck cancers) will receive different doses and formulations. The main goals are to check safety and how the drug moves through the body, not yet to see if it shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amivantamab (a drug that targets EGFR and cMet proteins on cancer cells)
- What this could lead to
- If successful, this could offer a more convenient way to deliver amivantamab as a shot under the skin instead of an IV infusion, potentially improving quality of life for people with certain advanced cancers.
- What could go wrong
- This is an early phase 1 study focused on safety and dosing, not on effectiveness. The drug may not work as well when given under the skin, or side effects could be different or worse. Results may not apply to all cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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158 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Part 1 and Part 2: Participant must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and which may derive benefit from epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transition tyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy. Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (CRC), renal cell cancer (RCC), medullary thyroid cancer (MTC), gastroesophageal cancer (GEC), mesothelioma, breast cancer (BC) and ovarian cancer (OC). Participants must have either progressed after prior standard of care therapy for metastatic disease, be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug * A man who is sexually active with a woman of childbearing potential must agree to use a condom and his partner must also be practicing a highly effective method of contraception (that is, established use of oral, injected or implanted hormonal methods of contraception; placement of an Intrauterine device \[IUD\] or Intrauterine system \[IUS\]) Exclusion criteria: * Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension or diabetes, ongoing or active systemic infection (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), diagnosed or suspected viral infection (except Human immunodeficiency virus \[HIV\] positive participants with 1 or more of the following: a) not receiving highly active antiretroviral therapy; b) a change in antiretroviral therapy within 6 months of the start of screening; c) cluster of differentiation 4 (CD4)+ T-cell count less than \[\<\]350 per cubic millimeters \[mm\^3\] at screening; d) an acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening), or psychiatric illness/social situation that would limit compliance with study requirements, including ability to self-care for anticipated toxicities \[that is. rash or paronychia\]. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded * Participant has had prior chemotherapy, targeted cancer therapy, or treatment with an investigational anti-cancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study drug; or participant has received prior immunotherapy within 6 weeks before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia \[any grade\], Grade less than or equal to \[\<=\] 2 peripheral neuropathy, and Grade less than \[\<\] 2 hypothyroidism stable on hormone replacement). Autoimmune toxicities from previous immunotherapy must be fully resolved to baseline levels * Participants with untreated brain metastases. Participants with locally treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (\<=10 milligrams \[mg\] prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible * Participant has an active malignancy other than the disease under study requiring treatment * Participant has leptomeningeal disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars Sinai Medical Center
West Hollywood, California, 90048, United States
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Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
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Community Health Network
Indianapolis, Indiana, 46256, United States
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Langone Health at NYC University, NYU School of Medicine
New York, New York, 10016, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
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Samsung Medical Center
Seoul, 06351, South Korea
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Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
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Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
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The Christie Nhs Foundation Trust
Manchester, M20 4BX, United Kingdom
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University Health Network
Toronto, Ontario, M5G 2M9, Canada
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