Phase
Condition
Neoplasms
Treatment
Ami-HC-CF
Ami-HC
Ami-LC-MD
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Part 1 and Part 2: Participant must have histologically or cytologically confirmedsolid malignancy that is metastatic or unresectable and which may derive benefitfrom epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transitiontyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy.Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cellcarcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectalcancer (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 therapyfor metastatic disease, be ineligible for, or have refused all other currentlyavailable therapeutic options. In cases where participants refuse currentlyavailable therapeutic options, this must be documented in the study records; Part 3:Participants with histologically or cytologically confirmed NSCLC with previouslyidentified EGFR mutation (identified locally in a Clinical Laboratory ImprovementAmendments [CLIA]-certified laboratory [or equivalent]) that is metastatic orunresectable and have progressed on or after at least one line of standard of caresystemic treatment for metastatic disease. Required prior therapy includes anapproved anti-EGFR tyrosine kinase inhibitor (TKI), or in the case of EGFR exon 20insertion mutation disease, platinum-based chemotherapy. A participant who hasrefused all other currently available therapeutic options is allowed to enroll andmust be documented in the study records
Participant must have Eastern Cooperative Oncology Group (ECOG) performance statusof 0 or 1
A woman of childbearing potential must have a negative serum (beta-human chorionicgonadotropin [beta-hCG]) at Screening and a negative urine or serum pregnancy testwithin 24 hours before the first dose of study drug
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assistedreproduction during the study and for 6 months after receiving the last dose ofstudy drug
A man who is sexually active with a woman of childbearing potential must agree touse a condom and his partner must also be practicing a highly effective method ofcontraception (that is, established use of oral, injected or implanted hormonalmethods of contraception; placement of an Intrauterine device [IUD] or Intrauterinesystem [IUS])
Exclusion
Exclusion criteria:
Participant has uncontrolled inter-current illness, including but not limited topoorly controlled hypertension or diabetes, ongoing or active systemic infection (that is, has discontinued all antibiotics for at least one week prior to first doseof study drug), diagnosed or suspected viral infection (except Humanimmunodeficiency virus [HIV] positive participants with 1 or more of the following:a) not receiving highly active antiretroviral therapy; b) a change in antiretroviraltherapy 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 6months of the start of screening), or psychiatric illness/social situation thatwould limit compliance with study requirements, including ability to self-care foranticipated toxicities [that is. rash or paronychia]. Participants with medicalconditions requiring chronic continuous oxygen therapy are excluded
Participant has had prior chemotherapy, targeted cancer therapy, or treatment withan investigational anti-cancer agent within 2 weeks or 4 half-lives, whichever islonger, before the first administration of study drug; or participant has receivedprior 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 4weeks. Toxicities from previous anticancer therapies should have resolved tobaseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade lessthan or equal to [<=] 2 peripheral neuropathy, and Grade less than [<] 2hypothyroidism stable on hormone replacement). Autoimmune toxicities from previousimmunotherapy must be fully resolved to baseline levels
Participants with untreated brain metastases. Participants with locally treatedmetastases that are clinically stable and asymptomatic for at least 2 weeks and whoare 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 requiringtreatment
Participant has leptomeningeal disease
Study Design
Connect with a study center
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Chungbuk National University Hospital
Cheongju-si, 28644
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
The Christie Nhs Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomSite Not Available
Cedars Sinai Medical Center
West Hollywood, California 90048
United StatesSite Not Available
Community Health Network
Indianapolis, Indiana 46256
United StatesSite Not Available
Langone Health at NYC University, NYU School of Medicine
New York, New York 10016
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
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