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Monoclonal Antibodies
Amivantamab SC for Cancer (PALOMA Trial)
Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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])
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years 1 month
Awards & highlights
PALOMA Trial Summary
This trial is testing a new way to give amivantamab, a cancer medicine, under the skin instead of through an IV. They want to see if it is safe and works the same as the IV form.
Who is the study for?
This trial is for adults with advanced solid tumors, like lung cancer, that have specific mutations and have worsened despite treatment. They must be relatively healthy otherwise, not planning to conceive, and willing to use contraception. People with brain metastases or uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests different ways of giving amivantamab—a drug targeting certain cancer growth factors—by injection under the skin. It aims to find the safest dose and method that can be absorbed properly by the body.See study design
What are the potential side effects?
Amivantamab may cause side effects such as skin reactions at the injection site, allergic reactions during infusion, fatigue, nausea, and possibly affect liver function. The severity of these side effects varies among individuals.
PALOMA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man who will use a condom and my partner uses birth control.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
PALOMA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amivantamab Steady-state Area Under the Curve (AUCss)
Number of Participants with Adverse Event (AE)
Number of Participants with Clinical Laboratory Abnormalities
+2 moreSecondary outcome measures
Epidermal Growth Factor Receptor (EGFR) Concentrations
Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
+3 morePALOMA Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ LazertinibExperimental Treatment3 Interventions
Participants will receive SC infusion of either Ami-HC-CF or Ami-HC in combination with lazertinib tablet.
Group II: Part 2: Ami-HC and Ami-HC-CFExperimental Treatment2 Interventions
Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or amivantamab co-formulated with rHuPH20 (Ami-HC-CF).
Group III: Part 1: Ami-LC-MD and Ami-LCExperimental Treatment2 Interventions
Participants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lazertinib
2021
Completed Phase 2
~770
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,934 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,512 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who will use a condom and my partner uses birth control.I have a certain type of cancer that cannot be removed by surgery and may benefit from specific targeted therapy.I haven't had cancer treatment in the last 2 weeks or longer, depending on the treatment type, and any side effects have mostly gone away.My NSCLC with an EGFR mutation has worsened despite treatment, including an anti-EGFR TKI or chemotherapy.I have brain metastases that are stable, and I've been off or on low-dose steroids for 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to the lining of my brain and spinal cord.I am being treated for another cancer besides the one being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Ami-HC and Ami-HC-CF
- Group 2: Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ Lazertinib
- Group 3: Part 1: Ami-LC-MD and Ami-LC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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