Clinical Trials /

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

NCT04606381

Description:

The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Esophagogastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Mesothelioma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Renal Cell Carcinoma
  • Thyroid Gland Medullary Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CR108891
  • SECONDARY ID: 2020-003225-36
  • SECONDARY ID: 61186372NSC1003
  • NCT ID: NCT04606381

Conditions

  • Advanced Solid Malignancies

Interventions

DrugSynonymsArms
Ami-LC-MDPart 1: Ami-LC-MD and Ami-LC
Ami-LCPart 1: Ami-LC-MD and Ami-LC
Ami-HCPart 2: Ami-HC and Ami-HC-CF
Ami-HC-CFPart 2: Ami-HC and Ami-HC-CF

Purpose

The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.

Trial Arms

NameTypeDescriptionInterventions
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.
  • Ami-LC-MD
  • Ami-LC
Part 2: Ami-HC and Ami-HC-CFExperimentalParticipants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or amivantamab co-formulated with rHuPH20 (Ami-HC-CF).
  • Ami-HC
  • Ami-HC-CF

Eligibility Criteria

        Inclusion criteria:

          -  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 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), 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Observed Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
Time Frame:Up to Day 29
Safety Issue:
Description:Ctrough is the observed serum concentration immediately prior to the next drug administration.

Secondary Outcome Measures

Measure:Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
Time Frame:Up to 3 years and 10 months
Safety Issue:
Description:Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed.
Measure:Epidermal Growth Factor Receptor (EGFR) Concentrations
Time Frame:Up to 3 years and 10 months
Safety Issue:
Description:EGRF concentrations markers will be assessed.
Measure:Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
Time Frame:Up to 3 years and 10 months
Safety Issue:
Description:cMET markers will be analyzed.
Measure:Overall Response Rate (ORR)
Time Frame:Up to 3 years and 10 months
Safety Issue:
Description:ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1.
Measure:Maximum Dosing Interval Between Time Zero to Steady State
Time Frame:Up to 3 years and 10 months
Safety Issue:
Description:Maximum dosing interval Between time zero to steady state will be assessed.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

October 22, 2020