Amivantamab SC for Cancer
(PALOMA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safe administration of amivantamab (Rybrevant) through an under-the-skin injection for certain advanced cancers. The goal is to determine the optimal dose and form of this treatment, with some participants also receiving lazertinib. Suitable candidates have advanced cancers such as lung, breast, or ovarian cancer and have either not responded to other treatments or cannot undergo them. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have had chemotherapy, targeted cancer therapy, or investigational anti-cancer agents within 2 weeks or 4 half-lives before starting the study drug. If you are on immunotherapy, you should have stopped it at least 6 weeks before starting the study drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that amivantamab, when injected under the skin, is generally safe. Studies have found its safety profile aligns with previous findings, revealing no new safety concerns. The most common side effects relate to the drug's action on certain proteins, including nail infections, low blood protein levels, and skin rashes.
Other studies have demonstrated that amivantamab is safe for treating a type of lung cancer with specific mutations. When combined with another cancer drug, lazertinib, its safety was comparable to previous intravenous uses, but with fewer and less severe side effects.
Overall, evidence suggests that amivantamab is well-tolerated when administered under the skin, with manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about amivantamab SC for cancer because it offers a new delivery method that sets it apart from traditional cancer treatments. Unlike standard intravenous infusions, amivantamab is administered subcutaneously, which could be more convenient for patients. Furthermore, this treatment combines amivantamab with rHuPH20, an enzyme that enhances drug dispersion, potentially improving efficacy. In some trial groups, amivantamab is also paired with lazertinib, which targets cancer cells more precisely, offering a powerful combination that could lead to better outcomes.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that injecting amivantamab under the skin yields promising results for treating certain cancers. In earlier studies, nearly half of the patients experienced tumor shrinkage, with a 45% overall response rate. On average, patients lived about 6.8 months without their cancer worsening. Additionally, 82% of patients saw their tumors shrink quickly and for a lasting period. In this trial, participants will receive different formulations of subcutaneous amivantamab, either alone or with lazertinib. The under-the-skin form of amivantamab matches the effectiveness of the intravenous form but offers greater safety. These findings suggest that this method of using amivantamab could be a strong option for cancer treatment.16789
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous infusion of amivantamab in various formulations and combinations, including Ami-HC, Ami-HC-CF, Ami-LC-MD, and Ami-LC, with or without lazertinib
Follow-up
Participants are monitored for safety, pharmacokinetics, and response rates, including adverse events and laboratory abnormalities
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University