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Monoclonal Antibodies

Amivantamab SC for Cancer (PALOMA Trial)

Phase 1
Recruiting
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])
Part 3: Participants with histologically or cytologically confirmed NSCLC with previously identified EGFR mutation (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent]) that is metastatic or unresectable and have progressed on or after at least one line of standard of care systemic treatment for metastatic disease. Required prior therapy includes an approved anti-EGFR tyrosine kinase inhibitor (TKI), or in the case of EGFR exon 20 insertion mutation disease, platinum-based chemotherapy. A participant who has refused all other currently available therapeutic options is allowed to enroll and must be documented in the study records
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 below
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I am a man who will use a condom and my partner uses birth control.
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My NSCLC with an EGFR mutation has worsened despite treatment, including an anti-EGFR TKI or chemotherapy.
Select...
I have a certain type of cancer that cannot be removed by surgery and may benefit from specific targeted therapy.
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I am fully active or restricted in physically strenuous activity but can do light work.

PALOMA Trial Timeline

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

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 more
Secondary 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 more

PALOMA 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
974 Previous Clinical Trials
6,384,096 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,742 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04606381 — Phase 1
Solid Tumors Research Study Groups: Part 2: Ami-HC and Ami-HC-CF, Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ Lazertinib, Part 1: Ami-LC-MD and Ami-LC
Solid Tumors Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT04606381 — Phase 1
Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04606381 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available slots for participants in this research?

"According to clinicaltrials.gov, the trial is actively recruiting participants since it was initially posted on November 10th 2020 and updated as recently as November 9th 2022."

Answered by AI

Is the scope of this clinical trial widespread in Canada?

"Seven medical centres are operating in this trial, including Cedars Sinai Medical Center (West Hollywood), Providence Portland Medical Center (Portland), and Langone Health at NYU School of Medicine (New york). Additionally, there are 4 other sites."

Answered by AI

What kind of risks are associated with the utilization of Ami-LC?

"Based on the existing evidence, our team assigned Ami-LC a safety score of 1 since this is an initial phase trial with limited data corroborating its efficacy and security."

Answered by AI

What is the total capacity of participants for this research trial?

"Affirmative. Clinicaltrials.gov provides evidence that this trial, whose inception was on November 10th 2020, is actively recruiting patients. Seven different clinical sites are admitting up to 196 participants in total."

Answered by AI

What is the ultimate goal of this clinical experiment?

"This trial will monitor a Cycle 4 (28 days) timespan to assess the primary outcome of Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough). Secondary objectives involve evaluating Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies, Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State, as well as Epidermal Growth Factor Receptor (EGFR) concentrations."

Answered by AI

Is this experiment unprecedented in the medical field?

"Ami-LC has been subject to 9 clinical trials across 37 nations, with 128 cities hosting at least one. The first trial of Ami-LC was a Janssen Research & Development sponsored program that began in 2016 and involved 780 individuals, who completed Phase 1 drug approval. Of the nine studies conducted since then, six have concluded their research data collection phases."

Answered by AI

Could you provide an overview of prior research that has focused on Ami-LC?

"Currently, 9 clinical trials studying Ami-LC are active with 3 of those being in a Phase 3. These studies have 1036 locations available worldwide; however, many are located in Sutton, Ontario."

Answered by AI
~22 spots leftby Oct 2024