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Small Molecule
RGX-104 Combination Therapy for Lung Cancer
Phase 1
Recruiting
Research Sponsored by Rgenix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient has an ECOG PS of ≤1
The patient must have histologic or cytologic evidence of a malignant solid tumor or lymphoma and must have advanced disease, defined as cancer that is either metastatic or locally advanced and unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, RGX-104, to see if it is safe and effective when used alone or with other drugs to treat different types of cancer.
Who is the study for?
Adults with advanced lung or endometrial cancer, who have tried standard treatments without success or for whom no standard treatment is likely to help. They must be in good physical condition (ECOG PS ≤1), not pregnant, and agree to use contraception. Exclusions include a history of pancreatitis, certain heart conditions, brain metastases, uncontrolled illnesses, HIV/Hepatitis B/C infection, and recent other treatments.Check my eligibility
What is being tested?
The trial tests RGX-104 alone or with other cancer drugs (nivolumab/ipilimumab/docetaxel/pembrolizumab plus carboplatin/pemetrexed) in patients whose cancers are resistant to standard therapies. It's a Phase 1 study focusing on safety and the right dose of RGX-104 when used singly or combined.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy like fatigue, skin reactions, digestive issues; chemotherapy-related hair loss and nausea; increased cholesterol/triglyceride levels due to RGX-104; as well as risks associated with liver-targeting drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
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My cancer is advanced, spreading, or cannot be removed by surgery.
Select...
My disease did not respond to or came back after standard treatment, or there is no effective standard treatment for it.
Select...
I am 18 years old or older.
Select...
My heart pumps blood normally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Carboplatin
Number of participants with treatment-emergent adverse events associated with RGX-104 treatment as a single agent, and separately, in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed.
Carboplatin
+1 moreSecondary outcome measures
Pharmacokinetics: Area Under the Curve (AUC) of RGX-104.
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of RGX-104.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Recurrent/Relapsed Small Cell Lung Cancer (SCLC) ExpansionExperimental Treatment1 Intervention
RGX-104 + docetaxel
RGX104 120 mg BID (5day on/2days off)
Group II: Recurrent/Relapsed Endometrial Cancer ExpansionExperimental Treatment2 Interventions
RGX-104 combined with ipilimumab
RGX104 120 mg BID (5day on/2days off)
Group III: Recurrent NSCLC (2nd/3rd Line Lung Cancer). ExpansionExperimental Treatment2 Interventions
RGX-104 in combination docetaxel
RGX104 120 mg BID (5day on/2days off)
Group IV: Newly dignosed NSCLC Cohort ExpansionExperimental Treatment4 Interventions
RGX104 + pembrolizumab + carboplatin/pemetrexed
RGX104 120 mg BID (5day on/2days off)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Docetaxel
FDA approved
Pembrolizumab
FDA approved
Carboplatin
FDA approved
Pemetrexed
FDA approved
Find a Location
Who is running the clinical trial?
Rgenix, Inc.Lead Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
Inspirna, Inc.Lead Sponsor
2 Previous Clinical Trials
110 Total Patients Enrolled
Robert Wasserman, MDStudy DirectorInspirna, Inc.
3 Previous Clinical Trials
151 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all my pre-disease activities without restriction.My cancer is advanced, spreading, or cannot be removed by surgery.I can choose to have a tumor biopsy in the later stages of the trial.My organs are functioning well.My heart pumps blood normally.I have had specific treatments within certain timeframes.I have a serious heart condition.I am on steroids or other drugs that weaken my immune system.The patient has a prolonged QTcF interval on their ECG.My disease did not respond to or came back after standard treatment, or there is no effective standard treatment for it.I am 18 years old or older.My blood counts are within a healthy range.I can provide a sample of my tumor before starting the study treatment.I still have major side effects from past cancer treatments.I am eligible for therapy combining nivolumab or ipilimumab.I have a serious lung condition that is not under control.I need medication that strongly affects liver enzyme CYP3A4.Your disease can be seen and measured using regular imaging tests.I am positive for HIV or have active/chronic Hepatitis B or C.I have high cholesterol or triglyceride levels.I have or might have cancer spread to my brain or its coverings.I have had pancreatitis before.If you have endometrial cancer and are taking part in the ipilimumab combination expansion stage, there are specific rules you need to meet.I need oxygen support to breathe.You have trouble swallowing pills or have a history of not taking medication as directed.I am eligible for a specific lung cancer treatment combination.I am a woman who can have children and I had a negative pregnancy test recently.I have another active cancer that could affect the study's results.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent NSCLC (2nd/3rd Line Lung Cancer). Expansion
- Group 2: Newly dignosed NSCLC Cohort Expansion
- Group 3: Recurrent/Relapsed Small Cell Lung Cancer (SCLC) Expansion
- Group 4: Recurrent/Relapsed Endometrial Cancer Expansion
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is RGX-104 a viable option for patient treatment with minimal risk?
"Due to the Phase 1 nature of this trial, our team at Power has evaluated RGX-104's safety as a score of 1 given its limited data on efficacy and security."
Answered by AI
How widely-dispersed are the sites offering this research study?
"Currently, 26 different trial sites are recruiting for this research initiative. These locations span from Louisville to Buffalo and many cities in between - so it is recommended that patients select the site closest to them to minimize travel costs."
Answered by AI
How many individuals can partake in this research endeavor?
"Affirmative. The information published on clinicaltrials.gov highlights that this trial is currently recruiting; it first appeared online on November 1st, 2016 and was last modified 15 days later in 2022 aiming to enroll 150 persons at 26 distinct medical centres."
Answered by AI
To what ailments has RGX-104 been demonstrated to provide relief?
"RGX-104 is routinely employed to address malignant melanoma of the skin, but it can also be useful for patients struggling with recurrent cervical cancer, refractory and relapsed mediastinal large B-cell lymphoma, or initial treatment."
Answered by AI
Are participants currently being welcomed for this research endeavor?
"According to information hosted on clinicaltrials.gov, this scientific trial is open and actively seeking participants. The study was initially uploaded on November 1st 2016, with latest edits occurring on November 15th 2022."
Answered by AI
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