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Ami-LC-MD

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment158
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04606381A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid MalignanciesPHASE1 ACTIVE NOT_RECRUITING 158Nov 10, 2020Apr 1, 2027Jun 5, 202612 United States, Canada +2
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Study Endpoints
Primary Endpoints
Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
Up to Day 29

Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.

Number of Participants with Adverse Event (AE)
Up to 4 years 1 month

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)
Up to Day 28

Number of participants with DLT will be assessed.

Number of Participants with Clinical Laboratory Abnormalities
Up to 4 years 1 month

Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.

Secondary Endpoints
Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
Up to 4 years 1 month
Epidermal Growth Factor Receptor (EGFR) Concentrations
Up to 4 years 1 month
Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
Up to 4 years 1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Ami-LC-MD and Ami-LCEXPERIMENTALParticipants 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.
Part 2: Ami-HC and Ami-HC-CFEXPERIMENTALParticipants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).
Interventions
NameTypeDescription
Ami-LC-MDDRUGParticipants will receive amivantamab admixed with rHuPH20 SC infusion.
Ami-LCDRUGParticipants will receive amivantamab SC infusion.
Ami-HCDRUGParticipants will receive amivantamab SC infusion.
Ami-HC-CFDRUGParticipants will receive amivantamab co-formulated with rHuPH20 as SC injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

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/hepatoc...

Countries:United StatesCanadaSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT04606381lastUpdatePostDate: changed
LOWJun 5, 2026NCT04606381lastUpdatePostDate: changed
LOWJun 5, 2026NCT04606381lastUpdatePostDate: changed
LOWJun 5, 2026NCT04606381lastUpdatePostDate: changed
LOWMay 26, 2026NCT04606381primaryCompletionDate: changed
LOWMay 24, 2026NCT04606381studyFirstPostDate: changed