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Small Molecule

RGX-104 Combination Therapy for Lung Cancer

Phase 1
Waitlist Available
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
Must not have
The patient has clinically significant cardiovascular disease
The patient has a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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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.
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My disease did not respond to or came back after standard treatment, or there is no effective standard treatment for it.
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I am 18 years old or older.
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My heart pumps blood normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition.
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I am on steroids or other drugs that weaken my immune system.
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I still have major side effects from past cancer treatments.
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I have a serious lung condition that is not under control.
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I need medication that strongly affects liver enzyme CYP3A4.
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I am positive for HIV or have active/chronic Hepatitis B or C.
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I have high cholesterol or triglyceride levels.
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I have or might have cancer spread to my brain or its coverings.
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I have had pancreatitis before.
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I need oxygen support to breathe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
132 Total Patients Enrolled
Inspirna, Inc.Lead Sponsor
2 Previous Clinical Trials
178 Total Patients Enrolled
Robert Wasserman, MDStudy DirectorInspirna, Inc.
3 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

RGX-104 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT02922764 — Phase 1
Lung Cancer Research Study Groups: Recurrent NSCLC (2nd/3rd Line Lung Cancer). Expansion, Newly dignosed NSCLC Cohort Expansion, Recurrent/Relapsed Small Cell Lung Cancer (SCLC) Expansion, Recurrent/Relapsed Endometrial Cancer Expansion
Lung Cancer Clinical Trial 2023: RGX-104 Highlights & Side Effects. Trial Name: NCT02922764 — Phase 1
RGX-104 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02922764 — Phase 1
~0 spots leftby Dec 2024
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