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Monoclonal Antibodies
INBRX-106 + Pembrolizumab for Lung Cancer
Verified Trial
Phase 1 & 2
Recruiting
Research Sponsored by Inhibrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has your disease progressed or came back despite treatment?
Do you have locally advanced or metastatic non-small cell lung cancer?
Must not have
Has your tumor tested positive for the EGFR mutations and/or the ALK gene? Check your biomarker test results.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a new drug to see if it is safe and effective at treating locally advanced or metastatic non small cell lung cancer when given in combination with pembrolizumab (Keytruda).
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer who have tried at least one standard of care treatment. They must not have certain gene mutations (EGFR, ALK) or prior exposure to OX40 agonists and should be free of serious heart conditions, active infections, and immune-related side effects from previous therapies.
What is being tested?
The study tests INBRX-106 alone and combined with Pembrolizumab (keytruda) in different doses to find the safest and most effective amount for treating solid tumors.
What are the potential side effects?
Possible side effects include typical immune therapy reactions like inflammation in various organs, skin rashes, fatigue, and potential worsening of existing heart conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease has worsened or returned after treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To assess the antitumor activity of INBRX-106 in combination with pembrolizumab
To assess the safety and tolerability of INBRX-106 in in combination with pembrolizumab
Secondary study objectives
To assess the immunogenicity of INBRX-106 in combination with pembrolizumab
To assess the pharmacokinetics of INBRX-106 in combination with pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort F3b: Priming dose followed by INBRX-106 and PembrolizumabExperimental Treatment0 Interventions
Priming dose of 0.3 mg/kg of INBRX-106 in the first cycle, followed by 0.1mg/kg of INBRX-106 + pembrolizumab 200mg every 3 weeks.
Group II: Cohort F3a: Alternating dosing of INBRX-106 and PembrolizumabExperimental Treatment1 Intervention
Alternating dosing of INBRX-106 0.3mg/kg + pembrolizumab 400mg every 6 weeks
Find a Location
Who is running the clinical trial?
Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,274 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,000 Total Patients Enrolled
Vasily Andrianov, MDStudy DirectorInhibrx, Inc.
4 Previous Clinical Trials
632 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with OX40 agonists.My non-squamous NSCLC lacks EGFR mutations and ALK rearrangements.My cancer has been tested for PD-L1, and for certain parts of the trial, any score is okay or a specific score is required.I do not have recent severe heart issues or uncontrolled high blood pressure.I have had brain metastases, but they are treated, not causing symptoms, and stable.I have completed at least one treatment cycle, like chemotherapy.My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.My tumor's PD-L1 level is at least 50%.My tumor is positive for EGFR mutations or ALK gene.My cancer has spread, doesn't respond to standard treatments, and surgery isn't an option.I have a history of hepatitis B, C, or HIV.I had severe side effects from previous immunotherapy that made me stop the treatment.I have advanced cancer and haven't been treated with CPI, or my cancer didn't respond to all standard treatments including CPI.My disease has worsened or returned after treatment.I have had an organ or bone marrow transplant.I have or had lung inflammation that needed treatment with steroids or other immune-suppressing drugs.I haven't taken antibiotics in the last 4 weeks.I have advanced or metastatic non-small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort F3b: Priming dose followed by INBRX-106 and Pembrolizumab
- Group 2: Cohort F3a: Alternating dosing of INBRX-106 and Pembrolizumab
Awards:
This trial has 1 awards, including:- 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.
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