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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

Must not have

Participant has leptomeningeal disease

Participant has an active malignancy other than the disease under study requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years 1 month

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who will use a condom and my partner uses birth control.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to the lining of my brain and spinal cord.

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I am being treated for another cancer besides the one being studied.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amivantamab Steady-state Area Under the Curve (AUCss)

Number of Participants with Adverse Event (AE)

Number of Participants with Clinical Laboratory Abnormalities

+2 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met